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Unictech Eye Mask 5.0 SC869.

by Unicskin Sl.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08436593271015 UDI-DI Date9 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Unictech Eye Mask 5.0
Generic Name
Cosmetic red-light phototherapy system, home-use
Model / Reference
SC869.
Primary DI / UDI-DI
08436593271015
FDA Product Code
ISA
GMDN Term
Cosmetic red-light phototherapy system, home-use
Device Class
Class I
Regulation Number
890.5660
GUDID distribution status
In Commercial Distribution

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Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number

Other properties (10)

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