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Luminance RED Cold Sore Device TN1927G

by Luminance Medical Ventures Incorporated

Listed FDA GUDID listing, no authorization on record

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 Number00850063220064 UDI-DI Date27 Jan 2026ListedStatusListed GUDID: 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  • Withdrawn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
Luminance RED Cold Sore Device
Generic Name
Infrared-light cold sore treatment device
Model / Reference
TN1927G
Primary DI / UDI-DI
00850063220064
510(k) Number
FDA Product Code
OKJ
GMDN Term
Infrared-light cold sore treatment device
Device Class
Class II
Regulation Number
878.4860
GUDID distribution status
In Commercial Distribution

Other devices from Luminance Medical Ventures Incorporated

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No