LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS— 510(k) K100610

Name: FDA 510(k) clearance K100610
Creator: U.S. Food and Drug Administration
Published: 2011-01-20

Substantially Equivalent

Lutronic Corporation

FDA 510(k) clearance K100610 for LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS, Substantially Equivalent on 2011-01-20. Applicant: Lutronic Corporation. Device class: 2.

Clearance details

Applicant: Lutronic Corporation
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2010-03-03
Decision date: 2011-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Reading, 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 Lutronic Corporation

view all

K251327 — XERF2025-08-11
K213748 — CoreLevee2022-10-14
K213569 — HOLLYWOOD SPECTRA Laser System2022-02-04
K203788 — DermaV Laser System2021-03-26
K183566 — CLARITY II Laser System2019-06-14

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