FDA Registration Active 🇺🇸 United States

CYNOSURE, LLC

Reg #: 1222993 · FEI: 1000120578 · Expires 2026
Products
23
Proprietary Names
150
Establishment Types
5
Classifications
23

Registration Details

Registration Name
CYNOSURE, LLC
Registration Number
1222993
FEI Number
1000120578
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
5 CARLISLE RD
City
Westford
State
MA
ZIP
01886
Country
US

Regulatory Submissions

510(k) Number
K072868

Owner / Operator

Firm Name
CYNOSURE, LLC
Operator Number
9006419
Address
5 CARLISLE ROAD, --
City
Westford
State
MA
Postal Code
01886
Country
US
Correspondent
Nicole - Getman

Products

Device Name Product Code
Powered Laser Surgical Instrument GEX
Laser For Disruption Of Adipocyte Cells For Aesthetic Use PKT
Electrosurgical Patient Return Electrode ODR
Retractor, Ophthalmic HNI
Laser, Cellulite Appearance OYW
Electrosurgical, Cutting & Coagulation & Accessories GEI
Tourniquet, Nonpneumatic GAX
Massager, Vacuum, Radio Frequency Induced Heat PBX
Bur, Dental EJL
Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Plier, Orthodontic JEX
Set, Anesthesia, Paracervical HEE
Massager, Vacuum, Light Induced Heating NUV
Retractor, All Types EIG
Pin, Retentive And Splinting, And Accessory Instruments EBL
Lamp, Infrared, Therapeutic Heating ILY
Massager, Therapeutic, Electric ISA
Apparatus, Exhaust, Surgical FYD
Electrode, Electrosurgical JOS
System, Suction, Lipoplasty MUU
Post, Root Canal ELR
Unit, Electrosurgical, And Accessories, Dental EKZ

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 LaseMD LEO Laser System Pelleve S5 IEC, Pelleve Gel, Surgitron 4 Dual RF S5 IEC REVLITE SI NON-SLIP GRIP TIP PLIERS 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 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 VECTUS Nubond Post, Screw HEALITE II SYSTEM Affirm DO SmartLipo MPX MICROSTAN FORCEPS, MICROSTAN RF FORCEPS, MINI MONO STAN RF FORCEPS Elite Laser SIDELAZE 800, PRECISION TX TriActive Workstation SURGITRON FFPF EMC BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 Reusable RF Laparoscopic Handpiece Reusable Baker Brow Probe Reusable LLETZ Electrodes Sterile LLETZ Bayonet Electrodes Reusable Giosis RF Elevator Reusable OTO-RAM Radiofrequency Assisted Myringotomy Handpieces (IEC-EE600/IEC-H604) Reusable Oval Loop Electrodes Reusable Javate/Khan Endo Forehead Suction Kit Reusable Rhinophyma Electrode Set Reusable 3" Length Handpiece with Patented Locking Chuck (IEC-XLP1) Reusable External Genital Lesion RF Electrodes Mono Stan RF Forceps, Bayonet Bipolar Forceps, Bipolar Forceps Sterile IEC-XBHP3 Reusable MicroInsulated Needle Handpiece Sterile RF Suction Coagulator Sterile Beigi Minimally Invasive Entropion Electrode Reusable Cryptolysis Electrode Reusable Javate/Khan RF Endoscopic Forehead Suction Probe Reusable Adenoid RF Electrode Reusable LLETZ Bayonet Electrodes Reusable Needle Electrodes Reusable Ophthalmic Micro-Dissection Electrodes Reusable Micro-Larynx RF Probes (Loop/Needle/Ball) Reusable Javate/Khan Coated Spade Suction Probe Reusable Insulated Needle Electrodes Reusable RF Assisted Tonsillotomy (RAT) Ball Electrodes Reusable RF Myringotomy Electrode Reusable Conization Electrodes Sterile Tongue Base Reduction Electrode Sterile MicroInsulated Needles Reusable RF Wedge Resection Electrodes Reusable Rodin® Microsurgery Handpiece Reusable Insulated Matrixectomy Electrodes Sterile RAUP Electrode Reusable Suction Coagulator Kit (H40) Sterile Sub-Mucosal VTR (UPP) Electrode Reusable Javate/Khan Coated Flate Scalpel Suction Probe Reusable Chedly Pucntal Occlusion (CPO) Electrodes Sterile RF Angled Suction Coagulator Sterile IEC-3FHPB/D Reusable RF Laparoscopic Electrodes Sterile Empire Microlncision Reusable MicroInsulated Needle Handpiece with Locking Chuck Reusable Blade Handpiece Reusable Insulated Sclerotherapy Needles Reusable Standard Podiatry Electrodes (S11B) Sterile Clear-Vu® Bayonet Electrodes Sterile Dermatology Electrode Reusable Javate Endoscopic DCR Electrodes Sterile Micro Fibre® Electrode Reusable 3" Length Handpiece with Patented Locking Chuck (XLP1) Reusable Patented 1 Button Fingerswitch Handpiece Reusable Round Loop Electrodes Reusable Foot-Controlled Handpiece Reusable Empire MicroTip Electrodes Reusable OTO-RAM Probe (1.5mm/2mm) THERACLEAR ADIVIVE SMOOTHSHAPES SYSTEM SmartLipo Laser CHEVEUX DIODE LASER SYSTEM POST KIT SMARTCOOL, CRYO 6, CRYO-C Cynergy PL Affirm Laser Dento-Surg 90 F.F.P. Elite MPX PICOSURE WORKSTATION, PICOSURE SKIN HOLLYWOOD SPECTRA Laser System Acclaim Laser ASPIRE PRECISION TX, SIDE LAZE 800 LASER BEAM DELIVERY SYSTEM ESTELUX/MEDILUX Q-YAG5 Nd:YAG Laser System TRIPLEX ER. YAG / ND: YAG SYSTEM ARTISAN PELLEVE GLIDESAFE

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Device in the United States for Export Only