Dermatrix Duo
FDA 510(k) clearance K251836 · decided 2026-02-06
Clearance details
- K-number
- K251836
- Device name
- Dermatrix Duo
- Applicant
- Shenzhen Gsd Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-16
- Decision date
- 2026-02-06
- Days to decision
- 235 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.