FDA Registration
Active
🇺🇸 United States
BIOPHOTAS, INC.
Reg #: 3009765778
·
FEI: 3009765778
·
Expires 2026
Products
5
Proprietary Names
34
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- BIOPHOTAS, INC.
- Registration Number
- 3009765778
- FEI Number
- 3009765778
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 15501 Red Hill Avenue, #200
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211038
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 |
|---|---|---|---|---|---|
| Laser, Comb, Hair | OAP | Class 2 | Physical Medicine | No | 2021-10-13 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2017-09-21 |
| Fat Reducing Low Level Laser | OLI | Class 2 | General, Plastic Surgery | No | 2024-03-15 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2024-03-15 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2016-12-16 |
Proprietary Names
Celluma MYSTIQUE
Celluma RESTORE
Celluma Series 2 ELITE
Celluma Series 2 RESTORE
Celluma Series 2 NOVA
Celluma Series 2 CONTOUR PLUS
Celluma HOME
Celluma LITE
Celluma ELITE
Celluma PRO
Celluma SKIN
Celluma CLEAR
Celluma POD
Celluma iLITE
Celluma FACE
Celluma SPORT
Celluma iPRO
Celluma DELUX
Celluma DELUX XL
Celluma Series 2 LITE
Celluma Series 2 PRO PLUS
Celluma Series 2 DELUX XL
Celluma Series 2 POD
Celluma Series 2 DELUX
Celluma Series 2 CONTOUR
Celluma Series 2 HOME
Celluma Series 2 PRO
Celluma Series 2 SKIN
Celluma Series 2 FACE
Celluma CONTOUR System
Celluma DELUX XL CONTOUR
Celluma PRO C3
Celluma DELUX CONTOUR
Celluma Series 2 SPORT
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device