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Mlay T2

by Shenzhen Mareal Tech Co., Ltd.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970275250094 UDI-DI Date15 May 2018ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Mlay
Generic Name
Cosmetic red-light phototherapy system, home-use
Model / Reference
T2
Primary DI / UDI-DI
06970275250094
510(k) Number
FDA Product Code
OHT
GMDN Term
Cosmetic red-light phototherapy system, home-use
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
Not in Commercial Distribution

Other devices from Shenzhen Mareal Tech Co., Ltd.

Properties

  • Over-the-Counter
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No