FDA Registration
Active
🇺🇸 United States
Celluma Series 2 ELITE
Reg #: 3009765778
·
FEI: 3009765778
·
Expires 2025
Products
3
Proprietary Names
15
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- BIOPHOTAS, INC.
- Registration Number
- 3009765778
- FEI Number
- 3009765778
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15501 Red Hill Avenue, #200
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232977
Owner / Operator
- Firm Name
- BioPhotas
- Operator Number
- 10041655
- Address
- 15501 Red Hill Ave., #200
- City
- Tustin
- State
- CA
- Postal Code
- 92780
- Country
- US
- Correspondent
- Donald Sherratt
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fat Reducing Low Level Laser | OLI | Class 2 | General, Plastic Surgery | No | 2024-03-15 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2024-03-15 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2024-03-15 |
Proprietary Names
Celluma Series 2 ELITE
Celluma Series 2 HOME
Celluma Series 2 CONTOUR PLUS
Celluma Series 2 NOVA
Celluma Series 2 PRO PLUS
Celluma Series 2 DELUX
Celluma Series 2 CONTOUR
Celluma Series 2 SPORT
Celluma Series 2 RESTORE
Celluma DELUX CONTOUR
Celluma Series 2 PRO
Celluma Series 2 DELUX XL
Celluma CONTOUR System
Celluma DELUX XL CONTOUR
Celluma Series 2 LITE
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device