Cleared Traditional

ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER

K021650 · Quantel Medical · General & Plastic Surgery

Aug 2002

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K021650 is an FDA 510(k) clearance for the ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Quantel Medical (Hot Springs, US). The FDA issued a Cleared decision on August 16, 2002, 88 days after receiving the submission on May 20, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K021650 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 2002
Decision Date	August 16, 2002
Days to Decision	88 days
Submission Type	Traditional
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.