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Mlay T14A

by Shenzhen Mlay Intelligent Technology Co., Ltd. 14 variants

Mlay T14A 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) K241106 on 22 May 2024 and listed in FDA GUDID since 15 Jul 2025 (UDI-DI 06977357491741), 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) K241106

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 Number06977357491741 UDI-DI Date15 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK241106 Date22 May 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241106 decided 22 May 2024 Active
  • FDA GUDID UDI-DI 06977357491741 listed 15 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241106
  2. Listed FDA GUDID 06977357491741

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  • Withdrawn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
T14A
Primary DI / UDI-DI
06977357491741
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)