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ELEMIS Red Light Mask TN2332

by iSMART Developments, Ltd.

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 Number05060534511521 UDI-DI Date7 Aug 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  • Withdrawn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
ELEMIS Red Light Mask
Generic Name
Cosmetic red-light phototherapy system, home-use
Model / Reference
TN2332
Primary DI / UDI-DI
05060534511521
FDA Product Code
OHS
GMDN Term
Cosmetic red-light phototherapy system, home-use
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution

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See all devices from iSMART Developments, Ltd. →

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

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
  • Premarket Exempt: No
  • Expiration Date: No