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AuraLux AS-SM-20000

by Acclaro Corporation

AuraLux AS-SM-20000 is a Class II device made by Acclaro Corporation, listed in FDA GUDID since 13 Jun 2025 (UDI-DI 00850039149085), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850039149085 UDI-DI Date13 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
AuraLux
Generic name
Dermatological solid-state laser system
Model / reference
AS-SM-20000
Primary DI / UDI-DI
00850039149085
FDA product code
GEX
GMDN term
Dermatological solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)