KCA441-200S
by Dongguan Boyuan Intelligent Technology Co., Ltd
KCA441-200S is a hair growth laser device (FDA Class II; FDA product code OAP, Laser, Comb, Hair) made by Dongguan Boyuan Intelligent Technology Co., Ltd, cleared under FDA 510(k) K250308 on 29 Apr 2025 and listed in FDA GUDID since 30 Jun 2026 (UDI-DI 26977638360616), 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 | Number26977638360616 | Date30 Jun 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250308 | Date29 Apr 2025 | StatusActive |
Official records
- AccessGUDID record 26977638360616
- FDA 510(k) database K250308
Across registries
- FDA 510(k) K250308 decided 29 Apr 2025 Active
- FDA GUDID UDI-DI 26977638360616 listed 30 Jun 2026 Listed
Timeline
- Cleared FDA 510(k) K250308
- Listed FDA GUDID 26977638360616
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Hair growth laser device
- Model / reference
- KCA441-200S
- Primary DI / UDI-DI
- 26977638360616
- 510(k) Number
- FDA product code
- OAP
- GMDN term
- Hair growth laser device
- Device class
- Class II
- Regulation number
- 890.5500
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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Other devices filed under FDA product code OAP (Laser, Comb, Hair).
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- LaserCap LC Pro and LC Elite by Transdermal Cap, Inc.
- Irradiation Cosmetic Device by Chongqing Peninsula Medical Technology Co., Ltd.
- CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) by Shenzhen Kaiyan Medical Equipment Co., Ltd
- IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM by Apira Science, Inc.
- Laser Hair Growth Devices (HR-H1) by Ziree Co., Ltd.
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