FDA Registration
Active
🇺🇸 United States
CUTERA, INC.
Reg #: 2954354
·
FEI: 3002900199
·
Expires 2026
Products
6
Proprietary Names
15
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- CUTERA, INC.
- Registration Number
- 2954354
- FEI Number
- 3002900199
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3240 BAYSHORE BLVD
- City
- BRISBANE
- State
- CA
- ZIP
- 94005
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122493
Owner / Operator
- Firm Name
- Cutera, Inc.
- Operator Number
- 9038697
- Address
- 3240 Bayshore Blvd.
- City
- Brisbane
- State
- CA
- Postal Code
- 94005
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2013-05-22 |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | Class 2 | General, Plastic Surgery | No | 2013-05-22 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-10-05 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2018-10-05 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2025-12-31 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2021-01-12 |
Proprietary Names
GenesisPlus
truSculpt, truSculpt 3D, truSculpt iD, truSculpt 40, truSculpt 16
AcuTip 500, Limelight, ProWave 770, ProWave LX
xeo+, xeo+ SA, Acutip, Limelight, Prowave
Solera Opus
Pearl Fractional
enlighten, enlighten SR, enlighten III
excel HR, excel V, excel V+
truFlex
Pearl
AviClear
CoolGlide CV, Excel, Vantage, Genesis
Titan XL
xeo, xeo SA
Solera Titan
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)