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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2007-12-14 |
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | Class 2 | General, Plastic Surgery | No | 2019-09-07 |
| Electrosurgical Patient Return Electrode | ODR | Class 2 | General, Plastic Surgery | No | 2017-09-27 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2014-10-06 |
| Laser, Cellulite Appearance | OYW | Class 2 | General, Plastic Surgery | No | 2014-05-19 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-06-26 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2016-08-29 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2024-05-10 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2014-10-06 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | Class 2 | General, Plastic Surgery | No | 2024-06-26 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2014-10-06 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2016-08-29 |
| Set, Anesthesia, Paracervical | HEE | Class 2 | Obstetrics/Gynecology | No | 2014-10-06 |
| Massager, Vacuum, Light Induced Heating | NUV | Class 2 | General, Plastic Surgery | No | 2011-02-07 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2016-08-29 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 2014-10-06 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2024-06-26 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2008-10-07 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2014-10-06 |
| Electrode, Electrosurgical | JOS | Class 2 | General, Plastic Surgery | No | 2014-10-07 |
| System, Suction, Lipoplasty | MUU | Class 2 | General, Plastic Surgery | No | 2013-10-21 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2014-10-06 |
| Unit, Electrosurgical, And Accessories, Dental | EKZ | Class 2 | Dental | No | 2014-10-06 |
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