FDA Registration
Active
🇺🇸 United States
Celluma Series 2 CONTOUR
Reg #: 3009765778
·
FEI: 3009765778
·
Expires 2025
Products
3
Proprietary Names
25
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
- K152280
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 |
|---|---|---|---|---|---|
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2016-12-16 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2016-12-16 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2016-12-16 |
Proprietary Names
Celluma Series 2 CONTOUR
Celluma Series 2 NOVA
Celluma LITE
Celluma PRO
Celluma HOME
Celluma ELITE
Celluma FACE
Celluma CLEAR
Celluma SPORT
Celluma Series 2 PRO PLUS
Celluma Series 2 LITE
Celluma DELUX XL
Celluma SKIN
Celluma Series 2 SKIN
Celluma Series 2 DELUX
Celluma DELUX
Celluma iPRO
Celluma RESTORE
Celluma Series 2 CONTOUR PLUS
Celluma Series 2 ELITE
Celluma Series 2 FACE
Celluma iLITE
Celluma POD
Celluma Series 2 DELUX XL
Celluma Series 2 PRO
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device