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KCA451-200S

by Dongguan Boyuan Intelligent Technology Co., Ltd

KCA451-200S 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 26977638360487), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K250308

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number26977638360487 UDI-DI Date30 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250308 Date29 Apr 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250308 decided 29 Apr 2025 Active
  • FDA GUDID UDI-DI 26977638360487 listed 30 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K250308
  2. Listed FDA GUDID 26977638360487

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Hair growth laser device
Model / reference
KCA451-200S
Primary DI / UDI-DI
26977638360487
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

Related devices

Cleared under the same submission (K250308)

Similar devices

Other devices filed under FDA product code OAP (Laser, Comb, Hair).

Other devices from Dongguan Boyuan Intelligent Technology Co., Ltd

See all devices from Dongguan Boyuan Intelligent Technology Co., Ltd →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)