handPICO 26378
handPICO 26378 is a Class II device made by Vydence Medical, cleared under FDA 510(k) K242534 on 20 Dec 2024 (1 earlier submission) and listed in FDA GUDID since 21 Jan 2025 (UDI-DI 07898961835426), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07898961835426 | Date21 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK242534 | Date20 Dec 2024 | StatusActive |
Official records
- AccessGUDID record 07898961835426
- FDA 510(k) database K242534
- FDA 510(k) database K220041
Across registries
- FDA 510(k) K242534 decided 20 Dec 2024 Active
- FDA GUDID UDI-DI 07898961835426 listed 21 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K220041
- Cleared FDA 510(k) K242534
- Listed FDA GUDID 07898961835426
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- handPICO
- Generic name
- Dermatological laser beam guiding handpiece
- Model / Ref / Catalog
- 26378
- Primary DI / UDI-DI
- 07898961835426
- FDA product code
- GEX
- GMDN term
- Dermatological laser beam guiding handpiece
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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