Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222993

FEI Number

1000120578

Entity Name

CYNOSURE, LLC

City/State/Country

Westford, MA, US

Establishment Address

5 CARLISLE RD, Westford, MA 01886, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

CYNOSURE, LLC (Owner Number: 9006419)

Owner / Operator Contact Address

5 CARLISLE ROAD, --, Westford, MA 01886, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K964176

PMA Number

N/A

All Registered Proprietary Names

Accolade Laser SCULPSURE, WARMSCULPT, PETITE MASK NEUTRAL PLATE PICOSURE WORKSTATION WITH 1064NM LASER DELIVERY SYSTEM CHEDLEY EYELID RETRACTOR V Star Laser APEX ER. YAG / IPL SYSTEM AFFINITY QS SCULPSURE CELLULAZE, SLT II LUTRONIC GENIUS ELLMAN DIGIT TOURNIQUETS TempSure System TempSure STARLUX 300, STARLUX 500 PhotoGenica SV Laser Roto-Pro, Non-Clogging Bur, Dental Bur MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE eCO2 Plus POLARIS Q-SWITCH RUBY SYSTEM ICON Elite iQ PRO (M122K1) CORNEAL SHIELDS Surgitron 4 Dual RFA/90 IEC, Surgitron 4 Dual RFA/120 IEC V Star Laser LaseMD LEO Laser System Pelleve S5 IEC, Pelleve Gel, Surgitron 4 Dual RF S5 IEC REVLITE SI NON-SLIP GRIP TIP PLIERS SCULPSURE Needle Extender/Measured Dose Syringe MEDLITE C6 PICOSURE VITALIA, TEMPSURE DermaV Laser System MEDLITE C1 Q-SWITCHED ND:YAG LASER SmartSkin CO2, SmartSkin+, Affirm CO2 Laser/Performa TEMPSURE, FLEXSURE CORTEX LASER SYSTEM TEMPSURE SYSTEM, TEMPSURE FIRM Cynergy Laser STARLUX 500 Apogee Laser SMARTSKIN+, SMARTSKIN Precision Tx, SLT II, SmartLipo Triplex PICOSURE LASER WORKSTATION, PICOSURE SKIN EMERGE PICOSURE, PICOSURE SKIN CLARITY II Laser System SCULPSURE RF Suction Adenoid Probes, Noble Alloy Electrodes Ace-Tip Electrodes, Bayonet Turbinate Electrode, Tonsillectomy Probe MOSAIC 3D Surgical Laser ELITE + LASER LUX 2940, LUX 1440, LUX 1540 SmoothShapes XV System and the Petite Photomology Module CORTEX CO2 / ER:YAG LASER SYSTEM REVLITE Elite iQ SELF SPAN CHEEK AND LIP RETRACTORS PICOSURE WORKSTATION WITH 532NM DELIVERY SYSTEM LUX 1540 HP PELLEFIRM Acusect, Radiolase II Pelleve Glidesafe Handpiece SCULPSURE VECTUS SCULPSURE PICOSURE LASER WORKSTATION, PICOSURE SKIN Nubond Post, Screw HEALITE II SYSTEM Affirm DO ICON SmartLipo MPX MICROSTAN FORCEPS, MICROSTAN RF FORCEPS, MINI MONO STAN RF FORCEPS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-14
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	Class 2	878.5400	2019-09-07
ODR	Electrosurgical Patient Return Electrode	General, Plastic Surgery	Class 2	878.4400	2017-09-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-07-07
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-10-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-05-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-10-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-06-13
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	Class 2	878.5400	2017-07-06
OYW	Laser, Cellulite Appearance	General, Plastic Surgery	Class 2	878.4810	2014-05-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-06-26
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2016-08-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-10
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2024-05-10
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-05-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-05-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-01-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-14
EJL	Bur, Dental	Dental	Class 1	872.3240	2014-10-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2011-11-16
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2024-06-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-06-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-10-06
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2016-09-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-09-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-03-12
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2014-10-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-10-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-06-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-10-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2011-11-16
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2016-08-29
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	Class 2	878.5400	2015-09-24
HEE	Set, Anesthesia, Paracervical	Obstetrics/Gynecology	Class 2	884.5100	2014-10-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2011-08-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-07-20
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2017-09-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-09-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-08-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2011-08-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2009-05-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-09-14
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2020-09-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-02-05
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2019-08-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-08-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-10-21
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-04-18
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2009-11-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-08-20
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2013-10-21
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-03-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-06-26
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	Class 2	878.5400	2016-09-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-10-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-04-02
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2025-04-02
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-09-17
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2013-10-21
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2011-02-07
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-10-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2011-08-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-03-12
EIG	Retractor, All Types	Dental	Class 1	872.4565	2016-08-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-06-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-01-28
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2014-10-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-10-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-10-06
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	Class 2	878.5400	2017-09-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-08-05
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	Class 2	878.5400	2015-09-24
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-11-03
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	Class 1	872.3740	2014-10-06
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-06-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2010-12-13
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-10-21
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2013-10-21
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2009-11-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-10-06

Official Correspondent

Nicole Getman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CYNOSURE, LLC

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
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-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-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222993. Last updated year: 2026. Please use registration number 1222993 when referencing this establishment in official correspondence.