Biophotas Celluma CONTOUR
FDA 510(k) clearance K232977 · decided 2023-11-21
Clearance details
- K-number
- K232977
- Device name
- Biophotas Celluma CONTOUR
- Applicant
- Biophotas, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-21
- Decision date
- 2023-11-21
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- OLI
- Device class
- 2
- Regulation number
- 878.5400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tustin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.