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Mlay T11A

by Shenzhen Mlay Intelligent Technology Co., Ltd. 4 variants

Mlay T11A 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 Shenzhen Mlay Intelligent Technology Co., Ltd., cleared under FDA 510(k) K240264 on 8 Mar 2024 and listed in FDA GUDID since 20 Jul 2026 (UDI-DI 06977357491314), 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) K240264

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 Number06977357491314 UDI-DI Date20 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240264 Date8 Mar 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240264 decided 8 Mar 2024 Active
  • FDA GUDID UDI-DI 06977357491314 listed 20 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240264
  2. Listed FDA GUDID 06977357491314

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mlay
Generic name
Home-use intense pulsed light hair removal unit
Model / reference
T11A
Primary DI / UDI-DI
06977357491314
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 Unsafe

Similar devices

Other devices filed under FDA product code OHT (Light Based Over-The-Counter Hair Removal).

Other devices from Shenzhen Mlay Intelligent Technology Co., Ltd.

  • Mlay T11A

    Class II
  • Dreame T32A

    Class II
  • Mlay T15A

    Class II
  • Mlay T16A

    Class II

See all devices from Shenzhen Mlay Intelligent Technology Co., Ltd. →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)