Cleared Traditional

MEGAPULSE LASER SYSTEM AND FIBERS

K090776 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery

Jun 2009

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K090776 is an FDA 510(k) clearance for the MEGAPULSE LASER SYSTEM AND FIBERS, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on June 2, 2009, 71 days after receiving the submission on March 23, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K090776 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2009
Decision Date	June 02, 2009
Days to Decision	71 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.