Cleared Special

SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS

K121127 · Cynosure, Inc. · General & Plastic Surgery

May 2012

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K121127 is an FDA 510(k) clearance for the SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS, 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 May 13, 2012, 30 days after receiving the submission on April 13, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K121127 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2012
Decision Date	May 13, 2012
Days to Decision	30 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.