Picoandy
Picoandy is a Class II device made by Wontech Co., Ltd, cleared under FDA 510(k) K234104 on 15 Mar 2024 and listed in FDA GUDID since 21 Mar 2024 (UDI-DI 08800022305914), active as of 21 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 | Number08800022305914 | Date21 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK234104 | Date15 Mar 2024 | StatusActive |
Official records
- AccessGUDID record 08800022305914
- FDA 510(k) database K234104
Across registries
- FDA 510(k) K234104 decided 15 Mar 2024 Active
- FDA GUDID UDI-DI 08800022305914 listed 21 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K234104
- Listed FDA GUDID 08800022305914
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- General/multiple surgical frequency-doubled solid-state laser system
- Model / reference
- PICOANDY
- Primary DI / UDI-DI
- 08800022305914
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- General/multiple surgical frequency-doubled solid-state laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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