KCA522
by Dongguan Boyuan Intelligent Technology Co., Ltd
KCA522 is a home-use intense pulsed light hair removal unit (FDA Class II; FDA product code OHT, Light Based Over-The-Counter Hair Removal) made by Dongguan Boyuan Intelligent Technology Co., Ltd, cleared under FDA 510(k) K250253 on 6 May 2025 and listed in FDA GUDID since 2 Jul 2026 (UDI-DI 06977638360728), 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 | Number06977638360728 | Date2 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250253 | Date6 May 2025 | StatusActive |
Official records
- AccessGUDID record 06977638360728
- FDA 510(k) database K250253
Across registries
- FDA 510(k) K250253 decided 6 May 2025 Active
- FDA GUDID UDI-DI 06977638360728 listed 2 Jul 2026 Listed
Timeline
- Cleared FDA 510(k) K250253
- Listed FDA GUDID 06977638360728
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Home-use intense pulsed light hair removal unit
- Model / reference
- KCA522
- Primary DI / UDI-DI
- 06977638360728
- 510(k) Number
- FDA product code
- OHT
- GMDN term
- Home-use intense pulsed light hair removal unit
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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