Cleared Traditional

WATERLASE IPLUS ALL TISSUE LASER

K122368 · Biolase Technology, Inc. · General & Plastic Surgery

May 2013

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K122368 is an FDA 510(k) clearance for the WATERLASE IPLUS ALL TISSUE LASER, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Biolase Technology, Inc. (Irvine, US). The FDA issued a Cleared decision on May 2, 2013, 269 days after receiving the submission on August 6, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K122368 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2012
Decision Date	May 02, 2013
Days to Decision	269 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.