Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611516

FEI Number

3002806863

Entity Name

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

City/State/Country

ZUIDLAND Zuid-Holland, NL

Establishment Address

SCHEIJDELVEWEG 2, ZUIDLAND Zuid-Holland NL-3214 VN, NL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

D.O.R.C. Dutch Ophthalmic Research Center (International) B. (Owner Number: 8030460)

Owner / Operator Contact Address

SCHEIJDELVEWEG 2, --, ZUIDLAND, NL-ZH 3214 VN, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190875

PMA Number

N/A

All Registered Proprietary Names

Illuminated Curved Laser probe Iris Retractor. Straight Laser Probe with Alcon adaptor Laser Probe, straight, with DORC connector Stepped Laserprobe, with Alcon connector Stepped Laserprobe, with DORC connector Laser Probe, curved, with DORC connector Curved Laser Probe with Alcon adaptor High flow viscous fluid extraction accessory Disposable Infusion Cannula Collection bag Disposable pack for viscous fluid extraction. DMEK Surgical Disposable Set Sterilization tray for 1 Micro-forceps/scissors. EVA NEXUS, Phaco vitrectomy system including laser with DORC connector EVA NEXUS Custom Phaco Pack 30 (Angled) Directional Laser Probe with Alcon / Lumenis connector EVA NEXUS cartridge with 0,5 L collection bag EVA NEXUS Irrigation and Aux. Aspiration Tubing EVA NEXUS, Phaco vitrectomy system EVA NEXUS Custom cartridge with 0,5 l collection bag EVA NEXUS Custom Phaco Pack 45 (Angled) 1cc syringe holder for micro-injection EVA NEXUS, Phaco vitrectomy system including laser with SMA connector EVA NEXUS Digital Overlay System EVA Nexus Infusion and Aux. Aspiration Tubing EVA NEXUS Custom Phaco Pack 45 (Straight) EVA Nexus Irrigation Tubing EVA NEXUS Custom Phaco Pack 30 (Straight) EVA Nexus Infusion Tubing EVA NEXUS Infusion Giving Set EVA NEXUS, Phaco emulsification system EVA NEXUS Combined TDC Pack EVA Nexus Aux. Aspiration Tubing Two Dimensional Cutter 20k CPM Directional Laser Probe with DORC connector EVA NEXUS Posterior TDC Pack D.A.L.K. Spatula Dissection Set Eckardt Membrane Pic Disposable Microscissors: Hooked Extendible curved spatula P.L.K. Scraper Disposable ILM Micro Pick Needle DMEK Sinskey Hook Down Disposable reversed Sinskey hook with irrigation Disposable Eckardt Membrane Pic Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier Spare bulb for REF: 1266.XIII Xenon BrightStar illumination System. Shielded TotalView Endoillumination Probe, including illuminated scleral depressor TotalView Endoillumination Probe, including illuminated scleral depressor TotalView Chandelier for cannula system TotalView Endoillumination Probe, with 2 exchangeable tips Disposable Chandelier fiber (one fiber) with Photon connector and guidance needle Eckardt TwinLight Chandelier with Photon connector and guidance needle Spaide TotalView Endoillumination Probe, including illuminated scleral depressor TotalView Chandelier for Eckardt cannula system 27G Chandelier fiber and 23G standard D-style fiber optic handpiece incl. guidance needle. Extendible Light Probe Disposable Eckardt Twinlight Chandelier Endoillumination Probe, including illuminated scleral depressor Disposable Chandelier fiber (one fiber) incl. guidance needle EVA, combined machine EVA, anterior machine EVA, combined machine including Laser (SMA connector) EVA, combined machine including Laser (DORC connector) Closure valves for cannula system. Cannula set with High Flow infusion line. One step stiletto insertor Disposable one step single cannula including inserter Single Trocar Disposable Universal silicone infusion line for cannula system. Two Step Cannula set with High Flow infusion line. Reusable Two step cannula system Disposable Two step vitrectomy system High Flow infusion line Disposable Hybrid Trocar System Disposable One step Cannula System 27G Ultra Short Disposable One-Step cannula system Reusable universal cannula Disposable Keratoscope. Reusable bipolar cord Charles Flute instrument. Backflush instrument with brush needle Eckardt Backflush Handpiece with luer lock Replacement Backflush Needle with silicone tip, straight. Large replacement backflush Reservoir Backflush Instrument with blunt needle Replacement backflush needle, straight Kusaka Scleral Depressor. Eckardt Pressure Plate Disposable Vitrectomy Lens Helsinki Hydrodissector (Curved) Korobelnik self-retaining infusion cannula Backflush Instrument with soft-tip cannula and active aspiration LASIK Irrigating Cannula, 2 Ports soft tipped cannulas Disposable High Myopic Backflush instrument, with brush needle and active aspiration Disposable Replacement backflush brush Needles Replacement backflush reservoir with active aspiration. Disposable viscous fluid injection / extraction cannula Disposable Backflush instrument, with extended silicone tip and active aspiration Cystotome (Short Curve) Formed Irr. Capsularhexis Disposable heavy silicon extraction cannula Disposable Backflush instrument, with brush needle and active aspiration Disposable Viscous Fluid Extraction cannula Disposable Shiraga Backflush instrument, with extendible brush tip and active aspiration Anaesthetic Cannula, Retrobulbar Atkinson Disposable Backflush instrument, with blunt needle and passive aspiration Lachrymal Cannula (Curved) Disposable Dual Bore PFC Cannula Replacement tubing for VFI Self Retaining Anterior Chamber Maintainer (Lewicky) Infusion line for infusion cannula I/A Cannula (Standard) 0.3mm port (Simcoe) Disposable Replacement backflush reservoirs. Cortex Extractor, 0.3mm Top port Extendible brush backflush instrument with active aspiration Anterior Chamber Cannula Rycroft Eftiar Dual Bore Cannula Replacement backflush needle Sauter Hydrodissector (Curved) Olive Tip Polisher (Curved) Disposable VFI cannula Backflush instrument with active aspiration Viscoelastic Cannula Angled Extendible subretinal injection needle Backflush Instrument with brush needle and active aspiration. Sub Tenons Cannula, curved with flattened tip Disposable Dual bore BSS injection needle Backflush Instrument with blunt needle and active aspiration Spaide soft-tipped diamond dusted cannula Disposable Shiraga Triamcinolone backflush instrument Formed Irrigating Cystotome Subretinal cannula, curved Backflush Instrument with blunt needle. Backflush Needle with tapered tip Disposable subretinal injection cannula Backflush Instrument with brush needle. Disposable Backflush instrument, with brush needle and passive aspiration Extendible subretinal injection cannula Disposable Microscissors: Straight Microscissors: Vertical Microscissors: Ovali Spatula / Scissors Microscissors: Straight Disposable Microscissors: Vertical Disposable Microscissors: Curved, Horizontal Microscissors: Curved, Horizontal EVA, combined machine EVA TDC Vitrectomy Pack VGPC Input 27G, Ultra short Cleaning adaptor for phaco sleeve Disposable EVA Drapes TotalView Endoillumination Probe, including illuminated scleral depressor Disposable EVA VGPC Input Set VFI Pack for Silicone Oil syringes EVA Flight Case Disposable High Speed TDC Cutter DORC Continuum range Disposable phaco set with 45 straight flared needle Exo diathermy handle with 45 curved tip, diameter 1.3 mm. Disposable phaco fragmentation needle, incl. wrench Shielded TotalView Endoillumination Probe, including illuminated scleral depressor 27G Ultra Short Disposable 8000 CPM TDC cutter Disposable phaco set with 45 angled flared needle Test chamber for phaco handpiece Triple step angled flared phaco needle 27G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depressor Safety filter for Zeiss/Moeller-Wedel Microscopes, Passive Universal PVC infusion line for 23G cannula system for VFI/VFE Featherlight micro Phaco emulsification/fragmentation handpiece. Safety filter for Zeis/Moeller-Wedel Microscopes, Manual Disposable infusion sleeve Disposable EVA Gravity Input Set Straight phaco needle Reusable phaco set with 30 straight flared needle EVA Cartridge with 0.5 L Collection Bag EVA Vitrectomy Pack Gravity Input Triple step flared phaco needle Reusable phaco set with 30 angled flared needle Safety filter for Leica Microscopes, Passive EVA, combined machine including Laser (DORC connector) Triple step angled flared phaco needle. (disposable) EVA, combined machine including Laser (SMA connector) Triple step flared phaco needle. (disposable) Endo-diathermy handle, straight pointed tip.(20 gauge / 0.9 mm) EVA Dust Cover Straight phaco needle. (disposable) Disposable test chamber for phaco handpiece Reusable phaco set with 45 angled flared needle Disposable EVA Accessory Set EVA Vitrectomy Pack VGPC Input Two Dimensional Cutter 16k CPM EVA Custom TDC Vitrectomy Pack VGPC Input Endoillumination Probe, including illuminated scleral depressor Disposable High Speed Cutter Disposable phaco set with 30 straight flared needle Endo-diathermy handle, straight pointed tip. Reusable phaco sleeve Disposable EVA Irrigation and Aspiration Tubing Reusable phaco set with 45 straight flared needle Disposable EVA Air Fluid Dual Tubing EVA TDC Vitrectomy Pack Gravity Input EVA, anterior machine Disposable EVA Collection Bag 0.5 L EVA TDC Vitrectomy Pack VGPC Input Phaco Sure Touch Handpiece Safety filter for Leica Microscopes, Manual Universal I/A handpiece, excl. tips Cleaning adapter for phaco needle Disposable EVA Double Irrigation Line with Air Exchange Bimanual irrigation/aspiration set Disposable infusion sleeve phaco needle including test chamber Bipolar Coagulation Forceps, 12 cm, angled, excl. cable Disposable frosted scleral depressor EVA Mayo Arm Diathermy cable Disposable tubings complete with filter for air-fluid exchange Irrigation sleeve for phaco needle. Straight tip for universal I/A handpiece Phaco emulsification handpiece. Disposable phaco set with 30 angled flared needle Curved tip for universal I/A handpiece Universal metal wrench for star phaco needles Disposable EVA Closure Plug Aspiration

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQB	Photocoagulator And Accessories	Ophthalmic	Class 2	886.4690	2018-10-18
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2003-09-16
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2006-06-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2006-06-22
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	1998-05-19
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2007-12-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-06-17
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-06-17
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2022-06-17
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2022-06-17
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-23
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2001-12-14
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2015-03-13
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2015-03-13
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2015-03-13
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2005-01-06
HJA	Photokeratoscope	Ophthalmic	Class 1	886.1350	1983-05-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-08-05
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2004-02-12
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2003-09-16
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	Ophthalmic	Class 2	886.1385	2007-12-14
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2002-03-19
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-23
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2019-09-26
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2019-09-26
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2019-09-26

Official Correspondent

Christian Schneider

US Agent Details

Minal Jamkhande Business: Dutch Ophthalmic USA Email: minal.jamkhande@zeiss.com Phone: (603) 7786929

Related Public Records

Same Entity

D.O.R.C. Dutch Ophthalmic Research Center (International) B.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K834060	F. & F. Koenigkramer	RELIANCE OPHTHALMIC SLIT LAMP R-083	1984-02-04
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0581-2026	Alcon Research LLC	2	CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1
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
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611516. Last updated year: 2026. Please use registration number 9611516 when referencing this establishment in official correspondence.