MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE— 510(k) K091446

Name: FDA 510(k) clearance K091446
Creator: U.S. Food and Drug Administration
Published: 2009-10-27

Substantially Equivalent

Palomar Medical Products, Inc.

FDA 510(k) clearance K091446 for MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE, Substantially Equivalent on 2009-10-27. Applicant: Palomar Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Palomar Medical Products, Inc.
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2009-05-15
Decision date: 2009-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONG

view all

K252155 — AVAVA Skin Treatment System2025-10-20
K244060 — eCO2 3D2025-07-31
K251031 — Fiber Laser Treatment Systems (HS-232,HS-233)2025-07-02
K250402 — AVAVA Skin Treatment System2025-04-14
K233550 — MOSAIC 3D (Surgical Laser)2024-01-02

More clearances from Palomar Medical Products, Inc.

view all

K111840 — EMERGE FRACTIONAL LASER2011-11-14
K092222 — THERMAPULSE2009-08-20
K090525 — LOI SYSTEM2009-06-01
K083900 — ERBIUM FRACTIONAL HANDPIECE2009-02-27
K083165 — PALOMAR ASPIRE LASER PLATFORM2009-02-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.