FDA Registration
Active
🇺🇸 United States
Ace-Tip Electrodes, Bayonet Turbinate Electrode, Tonsillectomy Probe
Reg #: 1222993
·
FEI: 1000120578
·
Expires 2025
Products
1
Proprietary Names
2
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
Regulatory Submissions
- 510(k) Number
- K071343
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 |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2014-10-06 |
Proprietary Names
Ace-Tip Electrodes, Bayonet Turbinate Electrode, Tonsillectomy Probe
RF Suction Adenoid Probes, Noble Alloy Electrodes
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198