Cleared Special

ELITE + LASER SYSTEM

K141425 · Cynosure, Inc. · General & Plastic Surgery

Sep 2014

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K141425 is an FDA 510(k) clearance for the ELITE + LASER SYSTEM, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Cynosure, Inc. (Wesford, US). The FDA issued a Cleared decision on September 11, 2014, 104 days after receiving the submission on May 30, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K141425 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2014
Decision Date	September 11, 2014
Days to Decision	104 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEX — Powered Laser Surgical Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.