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Unicled Helmet Omega 5.0 Hg-150B

by Unicskin Sl.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08436593271251 UDI-DI Date10 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Unicled Helmet Omega 5.0
Generic Name
Hair growth laser device
Model / Reference
HG-150B
Primary DI / UDI-DI
08436593271251
510(k) Number
FDA Product Code
OAP
GMDN Term
Hair growth laser device
Device Class
Class II
Regulation Number
890.5500
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K242363)

Other devices from Unicskin Sl.

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Properties

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

Other properties (11)

  • 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
  • Manufacturing Date: No