LUX1540, LUX1440 & LUX2940 LASER HANDPIECES— 510(k) K101506

Name: FDA 510(k) clearance K101506
Creator: U.S. Food and Drug Administration
Published: 2010-09-01

Substantially Equivalent

Palomar Medical Technologies, Inc.

FDA 510(k) clearance K101506 for LUX1540, LUX1440 & LUX2940 LASER HANDPIECES, Substantially Equivalent on 2010-09-01. Applicant: Palomar Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Palomar Medical Technologies, Inc.
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2010-06-01
Decision date: 2010-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

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