PRIMUS AESTHETIC PLATFORM— 510(k) K103664

Name: FDA 510(k) clearance K103664
Creator: U.S. Food and Drug Administration
Published: 2011-03-17

Substantially Equivalent

Palomar Medical Technologies, Inc.

FDA 510(k) clearance K103664 for PRIMUS AESTHETIC PLATFORM, Substantially Equivalent on 2011-03-17. 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: 2010-12-16
Decision date: 2011-03-17
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 Technologies, Inc.

view all

K130250 — QYAG LASER SYSTEM2013-05-03
K120622 — PALOMAR VECTUS LASER2012-05-23
K110907 — PALOMAR ICON (TM) AESTHETIC SYSTEM2011-06-22
K101506 — LUX1540, LUX1440 & LUX2940 LASER HANDPIECES2010-09-01
K100270 — ARTISAN AESTHETIC SYSTEM2010-03-29

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