FDA Registration
Active
🇺🇸 United States
Reusable External Genital Lesion RF Electrodes
Reg #: 1222993
·
FEI: 1000120578
·
Expires 2025
Products
1
Proprietary Names
56
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CYNOSURE, LLC
- Registration Number
- 1222993
- FEI Number
- 1000120578
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5 CARLISLE RD
- City
- Westford
- State
- MA
- ZIP
- 01886
- Country
- US
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 |
|---|---|---|---|---|---|
| Electrode, Electrosurgical | JOS | Class 2 | General, Plastic Surgery | No | 2014-10-07 |
Proprietary Names
Reusable External Genital Lesion RF Electrodes
Reusable OTO-RAM Radiofrequency Assisted Myringotomy Handpieces (IEC-EE600/IEC-H604)
Sterile Micro Fibre® Electrode
Reusable Blade Handpiece
Reusable RF Laparoscopic Handpiece
Reusable RF Wedge Resection Electrodes
Reusable Patented 1 Button Fingerswitch Handpiece
Reusable Insulated Sclerotherapy Needles
Reusable Standard Podiatry Electrodes (S11B)
Reusable RF Laparoscopic Electrodes
Reusable Rodin® Microsurgery Handpiece
Sterile RF Suction Coagulator
Sterile Dermatology Electrode
Reusable 3" Length Handpiece with Patented Locking Chuck (IEC-XLP1)
Reusable OTO-RAM Probe (1.5mm/2mm)
Reusable MicroInsulated Needle Handpiece with Locking Chuck
Reusable Cryptolysis Electrode
Reusable LLETZ Bayonet Electrodes
Sterile Tongue Base Reduction Electrode
Sterile MicroInsulated Needles
Reusable 3" Length Handpiece with Patented Locking Chuck (XLP1)
Sterile RAUP Electrode
Reusable Giosis RF Elevator
Reusable Foot-Controlled Handpiece
Reusable Adenoid RF Electrode
Sterile IEC-XBHP3
Reusable Needle Electrodes
Reusable Ophthalmic Micro-Dissection Electrodes
Sterile Clear-Vu® Bayonet Electrodes
Reusable MicroInsulated Needle Handpiece
Reusable Insulated Needle Electrodes
Sterile RF Angled Suction Coagulator
Reusable Javate Endoscopic DCR Electrodes
Reusable Javate/Khan Coated Spade Suction Probe
Sterile Sub-Mucosal VTR (UPP) Electrode
Reusable Baker Brow Probe
Reusable LLETZ Electrodes
Reusable RF Assisted Tonsillotomy (RAT) Ball Electrodes
Reusable RF Myringotomy Electrode
Sterile LLETZ Bayonet Electrodes
Reusable Oval Loop Electrodes
Reusable Javate/Khan Coated Flate Scalpel Suction Probe
Reusable Chedly Pucntal Occlusion (CPO) Electrodes
Reusable Empire MicroTip Electrodes
Reusable Suction Coagulator Kit (H40)
Sterile IEC-3FHPB/D
Reusable Conization Electrodes
Mono Stan RF Forceps, Bayonet Bipolar Forceps, Bipolar Forceps
Reusable Rhinophyma Electrode Set
Reusable Round Loop Electrodes
Sterile Empire Microlncision
Reusable Javate/Khan RF Endoscopic Forehead Suction Probe
Reusable Micro-Larynx RF Probes (Loop/Needle/Ball)
Reusable Javate/Khan Endo Forehead Suction Kit
Sterile Beigi Minimally Invasive Entropion Electrode
Reusable Insulated Matrixectomy Electrodes
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility