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World Aesthetix Broad Pulsed Light WAX161286

by World Aesthetix LLC

Listed FDA GUDID listing, not in commercial distribution

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 Number00850062978003 UDI-DI Date25 Jun 2024ListedStatusListed GUDID: not 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  • Withdrawn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
World Aesthetix Broad Pulsed Light
Generic Name
Intense pulsed light skin surface treatment system
Model / Reference
WAX161286
Primary DI / UDI-DI
00850062978003
510(k) Number
FDA Product Code
ONF
GMDN Term
Intense pulsed light skin surface treatment system
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K161286)

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

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