Skip to content

Omz-100 Neck

by GTG Wellness Co., Ltd.

Listed FDA GUDID listing, not in commercial distribution

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 Number08809520341165 UDI-DI Date17 Mar 2023ListedStatusListed GUDID: not 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  • Withdrawn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
Omz-100
Generic Name
Blue/red/infrared phototherapy lamp
Model / Reference
OMZ-100 NECK
Primary DI / UDI-DI
08809520341165
FDA Product Code
ILY
GMDN Term
Blue/red/infrared phototherapy lamp
Device Class
Class II
Regulation Number
890.5500
GUDID distribution status
Not in Commercial Distribution

Other devices from GTG Wellness Co., Ltd.

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No