VIKINI Main Unit DET Main Unit
VIKINI Main Unit DET Main Unit is a dermatological diode laser system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Ilooda.co., Ltd, cleared under FDA 510(k) K151232 on 6 Aug 2015 and listed in FDA GUDID since 15 Jan 2018 (UDI-DI 08800023200218), 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 | Number08800023200218 | Date15 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151232 | Date6 Aug 2015 | StatusActive |
Official records
- AccessGUDID record 08800023200218
- FDA 510(k) database K151232
Across registries
- FDA 510(k) K151232 decided 6 Aug 2015 Active
- FDA GUDID UDI-DI 08800023200218 listed 15 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K151232
- Listed FDA GUDID 08800023200218
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VIKINI Main Unit
- Generic name
- Dermatological diode laser system
- Model / Ref / Catalog
- DET Main Unit
- Primary DI / UDI-DI
- 08800023200218
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dermatological diode 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 diode laser system.
- SANO P-808, P-808L, P-808S, P-808W by Beijing Sano Lasers S&T Development Co., Ltd.
- Apolomed HS-816 by Shanghai Apolo Medical Technology Co., Ltd
- Leaf life LM-LNIRA by Shenzhen Leaflife Technology Co., Ltd.
- Leaf life LM-L808A by Shenzhen Leaflife Technology Co., Ltd.
- Venus Velocity VL000001 by Venus Concept Inc.
- Secret DUO Set Package MTR3.0 by CLASSYS Inc.