EQUINOX CO2 LASER SYSTEM— 510(k) K100487

Name: FDA 510(k) clearance K100487
Creator: U.S. Food and Drug Administration
Published: 2010-11-29

Substantially Equivalent

Eclipsemed Global, Inc.

FDA 510(k) clearance K100487 for EQUINOX CO2 LASER SYSTEM, Substantially Equivalent on 2010-11-29. Applicant: Eclipsemed Global, Inc.. Device class: 2.

Clearance details

Applicant: Eclipsemed Global, Inc.
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2010-02-19
Decision date: 2010-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, 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 Eclipsemed Global, Inc.

view all

K093465 — FUSION SYSTEM2010-01-05

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