SANDRO Dual
SANDRO Dual is a Class II device made by Wontech Co., Ltd, cleared under FDA 510(k) K252877 on 19 Dec 2025 (1 earlier submission) and listed in FDA GUDID since 16 Jun 2020 (UDI-DI 08800022304108), 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 | FDA 510(k)SESE | NumberK252877 | Date19 Dec 2025 | StatusActive |
| United States | GUDID listing | Number08800022304108 | Date16 Jun 2020 | StatusListed |
Official records
- AccessGUDID record 08800022304108
- FDA 510(k) database K252877
- FDA 510(k) database K200110
Across registries
- FDA 510(k) K252877 decided 19 Dec 2025 Active
- FDA GUDID UDI-DI 08800022304108 listed 16 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K200110
- Listed FDA GUDID 08800022304108
- Cleared FDA 510(k) K252877
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dermatological solid-state laser system
- Model / reference
- SANDRO Dual
- Primary DI / UDI-DI
- 08800022304108
- FDA product code
- GEX
- GMDN term
- Dermatological solid-state laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dermatological solid-state laser system.