Pastelle
Pastelle is a Class II device made by Wontech Co., Ltd, cleared under FDA 510(k) K250165 on 3 Jul 2025 (1 earlier submission) and listed in FDA GUDID since 16 Aug 2017 (UDI-DI 08800022300803), active as of 31 May 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 | NumberK250165 | Date3 Jul 2025 | StatusActive |
| United States | GUDID listing | Number08800022300803 | Date16 Aug 2017 | StatusListed |
Official records
- AccessGUDID record 08800022300803
- FDA 510(k) database K250165
- FDA 510(k) database K123293
Across registries
- FDA 510(k) K250165 decided 3 Jul 2025 Active
- FDA GUDID UDI-DI 08800022300803 listed 16 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K123293
- Listed FDA GUDID 08800022300803
- Cleared FDA 510(k) K250165
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dermatological frequency-doubled solid-state laser system
- Model / reference
- Pastelle
- Primary DI / UDI-DI
- 08800022300803
- FDA product code
- GEX
- GMDN term
- Dermatological frequency-doubled 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 frequency-doubled solid-state laser system.