Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002991496

FEI Number

3002991496

Entity Name

FCI FRANCE CHIRURGIE INSTRUMENTATION

City/State/Country

PARIS Ile-de-France, FR

Establishment Address

20-22 RUE LOUIS ARMAND, PARIS Ile-de-France 75015, FR

Establishment Type(s)

Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Carl Zeiss Meditec AG (Jena) (Owner Number: 9053564)

Owner / Operator Contact Address

Goeschwitzer Strasse 51-52, Jena, DE-TH 07745, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BOWMAN PROBE, BOWMAN PROBE SIZE 3 & 4 BOWMAN PROBE, BOWMAN PROBE SIZE 1 & 2 SIZER FOR SELF-RETAINING INTUBATION Sizer for LacriJet BOWMAN PROBE, BOWMAN PROBE SIZE 00 & 0 Membrane Pick 23 GA Membrane Pick 25 GA Mesh wrapped bioceramic orbital imp RETILOCK, 25GA NON-VALVED CANNULAS RETILOCK, 23GA NON-VALVED CANNULAS RETILOCK, 25GA VALVED CANNULAS RETILOCK, 23GA VALVED CANNULAS Retinal Strip Retinal Sleeve Retinal Sponge Retinal Band Retinal bands & strips Retinal Tire Retinal Tire (Type 276) BAND FOR REINFORCING SCLERA AT THE BACK OF THE EYE Nunchaku 90 mm Nunchaku 105 mm Single-Use Three-Mirrors Contact Lens 3 MIRRORS CONTACT LENS ( SINGLE USE ) Ritleng Bicanaliculus Intubation SELF-THREADING MONOKA, 4MM WIDE SELF-THREADING MONOKA, 4MM WIDE PVP SELF-THREADING MONOKA, 3MM MEDIUM Ritleng bicanalicular intubation SPHERE INTRODUCER SELF-RETAINING SET II (SRS II), 25MM SELF-RETAINING SET II (SRS II), 30MM SELF-RETAINING SET II (SRS II), 35MM DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA HORIZONTAL SCISSORS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA HORIZONTAL SCISSORS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA VERTICAL SCISSORS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA VERTICAL SCISSORS Curved Vitreoretinal Scissors 25 GA ANGLED 70 Degree VERTICAL VITREORETINAL SCISSORS 23 GA Curved Vitreoretinal Scissors 20 GA ANGLED 45 Degree VERTICAL VITREORETINAL SCISSORS 25 GA Straight Vitreoretinal Scissors with Rounded Blades 20 GA Curved Vitreoretinal Scissors 23 GA ANGLED 70 Degree VERTICAL VITREORETINAL SCISSORS 20GA ANGLED HORIZONTAL VITREORETINAL 55 Degree SCISSORS 1.7mm Blades 20 GA Claus Lucke Vertical Retinotomy Scissors 20 GA ANGLED 45 Degree HORIZONTAL VITREORETINAL SCISSORS 20 GA Retinal Tire Eptfe Retinal implants ePTFE SPONGE 3 mm ePTFE DUCOURNAU ® BAND 2 x 7 mm 4 x 3 mm ePTFE SPONGE (CHAUVAUD) ePTFE BAND 2.1 x 5.5 mm ePTFE SPONGE 2 x 5 mm ePTFE SPONGE 3 x 5 mm ePTFE HALF-SPONGE 2.5 x 7.5 mm 9 mm ePTFE STRIP (DESIGNED BY O. LEQUOY) ePTFE SPONGE 5 mm ePTFE SPONGE 4 mm ePTFE DUCOURNAU ® BAND 2.5 x 5.5 mm LacriJet NON-STERILE PLUGS, SLIM PLUGS 0.4MM SLIM MINI NON-STERILE PLUGS, SLANTED COLLARETTE PLUGS 0.7MM MINI NON-STERILE PLUGS, VARIETY PACK ASSORTED 6 PLUGS EACH NON-STERILE PLUGS, SLIM PLUGS 0.5MM SLIM PETITE Non-Sterile Plugs NON-STERILE PLUGS, SLANTED COLLARETTE PLUGS 0.6MM MICRO CRAWFORD Crawford Probe READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.8MM SMALL READY-SET PLUGS, SLIM PLUGS 0.4MM SLIM MINI READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.9MM MEDIUM READY-SET PLUGS, SLIM PLUGS 0.5MM SLIM PETITE READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.6MM MICRO READY-SET PLUGS, SLANTED COLLARETTE PLUGS 1MM LARGE READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.7MM MINI PRELOADED PUNCTAL PLUG (MINI US) - J.A. BERNARD TearSaver® 0.7 mm 2/box TearSaver® 0.6 mm 2/box PRELOADED PUNCTAL PLUG (EXTRA SMALL) - J.A. BERNARD PRELOADED PUNCTAL PLUG (SMALL) - J.A. BERNARD TearSaver® 0.4 mm 2/box TearSaver® 0.8 mm 2/box PRELOADED PUNCTAL PLUG STRAIGHT COLLARETTE (LARGE) PRELOADED PUNCTAL PLUG (MINI) - J.A. BERNARD PRELOADED PUNCTAL PLUG (REGULAR) - J.A. BERNARD PRELOADED PUNCTAL PLUG (LARGE) - J.A. BERNARD TearSaver® 0.5 mm 2/box PRELOADED PUNCTAL PLUG STRAIGHT COLLARETTE (SMALL) Wide Angle Fiber Optic Probe, Bausch & Lomb Stellaris PC Chandelier with Adjustable ring, Alcon Constellation Focus Fiber Optic Probe, Alcon Accurus Wide Angle Fiber Optic Probe, Alcon Accurus Chandelier with Adjustable ring, Bausch & Lomb Stellaris PC Wide Angle Fiber Optic Probe, Ocutome 5 mm connector Wide Angle Fiber Optic Probe, Bausch & Lomb Chandelier with Adjustable ring, Ocutome 5 mm connector Focus Fiber Optic Probe, Bausch & Lomb Millenium Shielded Fiber Optic Probe, Ocutome 5 mm connector Fiber Optic Probe, Ocutome 5 mm connector PERFORATED CONFORMERS, 26MM LARGE SILICONE CONFORMER SYMBLEPHARON RINGS, 25MM LARGE SYMBLEPHARON RINGS, 20MM SMALL SYMBLEPHARON RINGS, 22MM MEDIUM PERFORATED CONFORMERS, 23MM MEDIUM PERFORATED CONFORMERS, 20MM SMALL PUNCTAL GAUGES FOR READY-SET PLUGS, PUNCTAL GAUGE SET 6 GAUGE SIZES (3 INSTRUMENTS) LASER PROBES, 20GA STRAIGHT TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 25GA CURVED TIP DORC LASER PROBES, 20GA CURVED TIP DORC LASER PROBES, 20GA STRAIGHT TIP DORC LASER PROBES, 27GA STRAIGHT TIP DORC LASER PROBES, 27GA STRAIGHT TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 23GA STRAIGHT TIP DORC LASER PROBES, 23GA CURVED TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 25GA FLEXIBLE CURVED TIP DORC LASER PROBES, 20GA CURVED TIP QUANTEL LASER PROBES, 25GA CURVED TIP ALCON/COHERENT/ZEISS/0S4 LASER PROBES, 25GA STRAIGHT TIP QUANTEL LASER PROBES, 23GA STRAIGHT TIP ALCON/COHERENT/ZEISS/0S4 LASER PROBES, 20GA CURVED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 25GA CURVED TIP QUANTEL LASER PROBES, 20GA STRAIGHT TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 27GA STRAIGHT TIP ALCON/COHERENT/ZEISS/0S4 LASER PROBES, 25GA STRAIGHT TIP ALCON/COHERENT/ZEISS/0S4 LASER PROBES, 20GA CURVED TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 25GA FLEXIBLE CURVED TIP ALCON/COHERENT/ZEISS/ELLEX/0S4 LASER PROBES, 23GA CURVED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 27GA STRAIGHT TIP QUANTEL LASER PROBES, 25GA FLEXIBLE CURVED TIP QUANTEL LASER PROBES, 23GA CURVED TIP DORC LASER PROBES, 25GA STRAIGHT TIP DORC LASER PROBES, 25GA STRAIGHT TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 23GA FLEXIBLE CURVED TIP QUANTEL LASER PROBES, 23GA STRAIGHT TIP QUANTEL LASER PROBES, 25GA CURVED TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 20GA STRAIGHT TIP QUANTEL LASER PROBES, 25GA CURVED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 25GA FLEXIBLE CURVED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 23GA CURVED TIP ALCON/COHERENT/ZEISS/0S4 LASER PROBES, 23GA FLEXIBLE CURVED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 23GA FLEXIBLE CURVED TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 25GA FLEXIBLE CURVED TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 23GA FLEXIBLE CURVED TIP DORC LASER PROBES, 23GA STRAIGHT TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 25GA STRAIGHT TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 23GA CURVED TIP QUANTEL LASER PROBES, 27GA STRAIGHT TIP IRIDEX/BAUSCH & LOMB LASER PROBES, 23GA FLEXIBLE CURVED TIP ALCON/COHERENT/ZEISS/ELLEX/0S4 LASER PROBES, 23GA STRAIGHT TIP NIDEK/LUMENIS NOVUS SPECTRA LASER PROBES, 20GA STRAIGHT TIP ALCON/COHERENT/ZEISS/0S4 Tissue Expander Hemisphere 0,9ml Tissue Expander Hemisphere 0,9ml/P Tissue Expander Sphere 1ml Tissue Expander Hemisphere 1,5ml Tissue Expander Sphere 4ml Tissue Expander Hemisphere 0,4ml Tissue Expander Sphere 5ml Tissue Expander Hemisphere 2ml Tissue Expander Sphere 2ml Tissue Expander Sphere 3ml LASER ILLUMINATION PROBES, 25GA CURVED ILLUMINATED TIP QUANTEL LASER ILLUMINATION PROBES, 20GA CURVED ILLUMINATED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER ILLUMINATION PROBES, 23GA CURVED ILLUMINATED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER ILLUMINATION PROBES, 25GA STRAIGHT ILLUMINATED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER ILLUMINATION PROBES, 20GA STRAIGHT ILLUMINATED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER ILLUMINATION PROBES, 27GA STRAIGHT ILLUMINATED TIP ALCON/COHERENT/ZEISS/ELLEX/0S4 LASER ILLUMINATION PROBES, 23GA CURVED ILLUMINATED TIP IRIDEX/BAUSCH & LOMB LASER ILLUMINATION PROBES, 23GA CURVED ILLUMINATED TIP DORC LASER ILLUMINATION PROBES, 20GA STRAIGHT ILLUMINATED TIP DORC LASER ILLUMINATION PROBES, 23GA STRAIGHT ILLUMINATED TIP IRIDEX/BAUSCH & LOMB LASER ILLUMINATION PROBES, 20GA CURVED ILLUMINATED TIP QUANTEL LASER ILLUMINATION PROBES, 20GA CURVED ILLUMINATED TIP DORC LASER ILLUMINATION PROBES, 23GA CURVED ILLUMINATED TIP ALCON/COHERENT/ZEISS/ELLEX/0S4 LASER ILLUMINATION PROBES, 25GA STRAIGHT ILLUMINATED TIP QUANTEL LASER ILLUMINATION PROBES, 27GA STRAIGHT ILLUMINATED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER ILLUMINATION PROBES, 25GA CURVED ILLUMINATED TIP IRIDEX/BAUSCH & LOMB LASER ILLUMINATION PROBES, 20GA CURVED ILLUMINATED TIP ALCON/COHERENT/ZEISS/ELLEX/0S4 LASER ILLUMINATION PROBES, 25GA STRAIGHT ILLUMINATED TIP DORC LASER ILLUMINATION PROBES, 23GA STRAIGHT ILLUMINATED TIP QUANTEL LASER ILLUMINATION PROBES, 20GA CURVED ILLUMINATED TIP IRIDEX/BAUSCH & LOMB LASER ILLUMINATION PROBES, 27GA STRAIGHT ILLUMINATED TIP IRIDEX/BAUSCH & LOMB LASER ILLUMINATION PROBES, 25GA CURVED ILLUMINATED TIP ALCON/COHERENT/ZEISS/ELLEX/0S4 LASER ILLUMINATION PROBES, 27GA STRAIGHT ILLUMINATED TIP QUANTEL LASER ILLUMINATION PROBES, 23GA STRAIGHT ILLUMINATED TIP DORC LASER ILLUMINATION PROBES, 25GA STRAIGHT ILLUMINATED TIP ALCON/COHERENT/ZEISS/ELLEX/0S4 LASER ILLUMINATION PROBES, 25GA STRAIGHT ILLUMINATED TIP IRIDEX/BAUSCH & LOMB LASER ILLUMINATION PROBES, 27GA STRAIGHT ILLUMINATED TIP DORC LASER ILLUMINATION PROBES, 20GA STRAIGHT ILLUMINATED TIP QUANTEL LASER ILLUMINATION PROBES, 23GA CURVED ILLUMINATED TIP QUANTEL LASER ILLUMINATION PROBES, 20GA STRAIGHT ILLUMINATED TIP ALCON/COHERENT/ZEISS/ELLEX/0S4 LASER ILLUMINATION PROBES, 25GA CURVED ILLUMINATED TIP DORC LASER ILLUMINATION PROBES, 25GA CURVED ILLUMINATED TIP NIDEK/LUMENIS NOVUS SPECTRA LASER ILLUMINATION PROBES, 20GA STRAIGHT ILLUMINATED TIP IRIDEX/BAUSCH & LOMB DISPOSABLE TANO POLISHER, 20GA DISPOSABLE TANO POLISHER, 25GA DISPOSABLE TANO POLISHER, 23GA EZYPOR STOPLOSS, 3.5MM 9MM STOPLOSS, 3.5MM 10MM STOPLOSS, 3.5MM 21MM STOPLOSS, 3.5MM 15MM STOPLOSS, 3.5MM 16MM STOPLOSS, 3.5MM 14MM STOPLOSS, 3.5MM 18MM STOPLOSS, 4MM 14MM STOPLOSS, 3.5MM 19MM STOPLOSS JONES TUBE INTRODUCER SET STOPLOSS, 4MM 15MM STOPLOSS, 3.5MM 12MM STOPLOSS, 3.5MM 22MM STOPLOSS, 3.5MM 17MM STOPLOSS, 3.5MM 11MM STOPLOSS, 4MM 16MM STOPLOSS, 4MM 13MM STOPLOSS, 3.5MM 13MM STOPLOSS, 4MM 22MM STOPLOSS, 4MM 19MM STOPLOSS, 4MM 21MM STOPLOSS, 4MM 9MM STOPLOSS, 4MM 18MM STOPLOSS, 4MM 17MM STOPLOSS, 4MM 11MM STOPLOSS, 4MM 10MM STOPLOSS JONES TUBE REMOVAL TOOL STOPLOSS, 4MM 12MM STOPLOSS, 3.5MM 20MM STOPLOSS, 4MM 20MM MASTERKA REUSABLE DOUBLE DILATOR, FINE & MEDIUM TAPERS DISPOSABLE PUNCTUM DILATOR & PLUG INSERTER LACRIMAL DILATOR DISPOSABLE Disposable Punctum Dilator Silicone Orbital Implants Enucleation/evisceration implants ENUCLEATION/EVISCERATION DISPOSABLE SIZERS Crawford Bicanaliculus Intubation Ptose-Up Ptose Up 3 mm Width J.M. Ruban, M.D. Ptose Up 2 mm Width J.M. Ruban, M.D. Ptosis Sling Ptosis Strip Ocular Shield WIDE/MEDIUM COLLARETTE MONOKA, 3MM MEDIUM MONO-CRAWFORD, 3MM MEDIUM COLLARETTE BOX OF 1 WIDE/MEDIUM COLLARETTE MONOKA, 4MM WIDE MONO-CRAWFORD, 4MM WIDE COLLARETTE BOX OF 3 MONO-CRAWFORD, 3MM MEDIUM COLLARETTE BOX OF 3 MONO-CRAWFORD, 4MM PVP WIDE COLLARETTE BOX OF 1 MONO-CRAWFORD, 3MM PVP MEDIUM COLLARETTE BOX OF 3 MONO-CRAWFORD, 3MM PVP MEDIUM COLLARETTE BOX OF 1 MONO-CRAWFORD, 4MM WIDE COLLARETTE BOX OF 1 MONO-CRAWFORD, 4MM PVP WIDE COLLARETTE BOX OF 3 Painless Plug Snug Plug FCI Prolong Plug disposable infusion cannula surgical knife Disposable vitrectomy lens DISPOSABLE SIZERS INVITRIA INTRAVITREAL INJECTION ASSISTANT Goncalves Invitria Precivia Version I Precivia Version P Non-Sterile Precivia Version P Precivia Version I Non-Sterile Ritleng+ PVP Ritleng+ Bige II Self-Retaining Bicanaliculus Intubation Set II Watzke Sleeve Spreading Forceps ENDONASAL FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA SERRATED FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA END-GRASPING FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA ECKARDT (MACULORHEXIS) FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA SERRATED FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA TANO FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA ECKARDT (MACULORHEXIS) FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA TANO FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA END-GRASPING FORCEPS Diamonized End-Gripping Vitreoretinal Forceps 25 GA Eckardt End-Gripping Forceps 20 GA PICK Vitreoretinal Forceps 25 GA Tano Assymmetrical End-Gripping Forceps 23 GA Vitreoretinal End-Gripping Forceps with Serrated Jaws 20 GA Flushing Adaptor (for vitreoretinal forceps/tips) ILM Vitreoretinal End-Gripping Forceps 20 GA Foreign Body Forceps 17 GA PICK Vitreoretinal Forceps 20 GA PICK Vitreoretinal Forceps 23 GA ILM Vitreoretinal End-Gripping Forceps 23 GA Angled Horizontal Subretinal Gripping Forceps 3 mm Tip 20 GA Diamonized End-Gripping Vitreoretinal Forceps 20 GA Eckardt End-Gripping Forceps 23 GA Eckardt End-Gripping Forceps 25 GA Tano Assymmetrical End-Gripping Forceps 25 GA Diamonized End-Gripping Vitreoretinal Forceps 23 GA Angled Horizontal Diamonized Gripping Forceps 20 GA Tano Assymmetrical End-Gripping Forceps 20 GA Forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	1999-10-05
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-09-05
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2009-03-11
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-05
HQX	Implant, Orbital, Extra-Ocular	Ophthalmic	Class 2	886.3340	2009-03-11
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2016-11-04
HJL	Lens, Condensing, Diagnostic	Ophthalmic	Class 1	886.1380	2016-08-02
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2009-03-11
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	1999-10-05
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2009-03-11
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-11-04
HQX	Implant, Orbital, Extra-Ocular	Ophthalmic	Class 2	886.3340	2009-03-11
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2021-01-06
LZU	Plug, Punctum	Unknown	Class U	N/A	2009-03-11
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2009-02-20
LZU	Plug, Punctum	Unknown	Class U	N/A	2009-02-20
FFS	Image, Illumination, Fiberoptic, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2016-02-24
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	1999-10-05
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2003-04-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2012-12-13
NFM	Expander, Tissue, Orbital	Ophthalmic	Class 2	886.3320	2016-11-11
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2012-12-13
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2016-11-04
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2022-06-24
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2015-10-22
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2012-09-10
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	1999-06-29
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2009-03-11
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2012-09-10
HJZ	Crutch, Ptosis	Ophthalmic	Class 1	886.5600	2002-01-29
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-01-31
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2009-03-11
LZU	Plug, Punctum	Unknown	Class U	N/A	2009-03-11
LZU	Plug, Punctum	Unknown	Class U	N/A	2019-07-17
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-03-11
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	Ophthalmic	Class 2	886.1385	2009-03-11
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-03-11
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-04-11
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2021-03-12
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2013-12-18
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

Paul Swift Business: CARL ZEISS MEDITEC USA, INC. Email: fdaagent.med.us@zeiss.com Phone: (817) 9258507

Related Public Records

Same Entity

Carl Zeiss Meditec AG (Jena)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015534077	Carl Zeiss Meditec Digital Innovations Inc	Temple, TX, US
3032734659	Carl Zeiss Meditec (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
3010126268	Carl Zeiss Meditec Production, LLC.	Ontario, CA, US
2918630	CARL ZEISS MEDITEC INC	DUBLIN, CA, US
9615010	CARL ZEISS MEDITEC AG (OBERKOCHEN)	OBERKOCHEN Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2007	Integrated Orbital Implants Inc	2	Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
Z-0308-2026	Alcon Research LLC	1	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002991496. Last updated year: 2026. Please use registration number 3002991496 when referencing this establishment in official correspondence.