QuRAS Main Unit QND Main Unit
QuRAS Main Unit QND Main Unit is a Class II device made by Ilooda.co., Ltd, cleared under FDA 510(k) K173038 on 1 Dec 2017 and listed in FDA GUDID since 16 Jan 2018 (UDI-DI 08800023200249), 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 | Number08800023200249 | Date16 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173038 | Date1 Dec 2017 | StatusActive |
Official records
- AccessGUDID record 08800023200249
- FDA 510(k) database K173038
Across registries
- FDA 510(k) K173038 decided 1 Dec 2017 Active
- FDA GUDID UDI-DI 08800023200249 listed 16 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K173038
- Listed FDA GUDID 08800023200249
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QuRAS Main Unit
- Generic name
- Dermatological frequency-doubled solid-state laser system
- Model / reference
- QND Main Unit
- Primary DI / UDI-DI
- 08800023200249
- 510(k) Number
- 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.