HYPERION Red Handpiece
HYPERION Red Handpiece is a Class II device made by Laseroptek Co., Ltd, cleared under FDA 510(k) K132286 on 22 Jan 2014 and listed in FDA GUDID since 12 Jan 2018 (UDI-DI 08800035500443), active as of 8 Jun 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 | Number08800035500443 | Date12 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132286 | Date22 Jan 2014 | StatusActive |
Official records
- AccessGUDID record 08800035500443
- FDA 510(k) database K132286
Across registries
- FDA 510(k) K132286 decided 22 Jan 2014 Active
- FDA GUDID UDI-DI 08800035500443 listed 12 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K132286
- Listed FDA GUDID 08800035500443
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dermatological solid-state laser system
- Model / reference
- HYPERION Red Handpiece
- Primary DI / UDI-DI
- 08800035500443
- 510(k) Number
- 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.