XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)— 510(k) K013511

Name: FDA 510(k) clearance K013511
Creator: U.S. Food and Drug Administration
Published: 2002-02-01

Substantially Equivalent

Aculux, Inc.

FDA 510(k) clearance K013511 for XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~), Substantially Equivalent on 2002-02-01. Applicant: Aculux, Inc.. Device class: 2.

Clearance details

Applicant: Aculux, Inc.
Product code: Code FSW
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2001-10-22
Decision date: 2002-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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