DermaSensor
FDA 510(k) clearance DEN230008 · decided 2024-01-12
Clearance details
- K-number
- DEN230008
- Device name
- DermaSensor
- Applicant
- Dermasensor, Inc.
- Decision
- Unknown
- Date received
- 2023-02-02
- Decision date
- 2024-01-12
- Days to decision
- 344 days
- Clearance type
- Direct
- Product code
- QZS
- Device class
- 2
- Regulation number
- 878.1830
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.