Cleared Traditional

MICRORUPTOR 6

K160677 · Meridian AG · General & Plastic Surgery

May 2017

Decision

435d

Days

Class 2

Risk

About This 510(k) Submission

K160677 is an FDA 510(k) clearance for the MICRORUPTOR 6, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Meridian AG (Thun, CH). The FDA issued a Cleared decision on May 19, 2017, 435 days after receiving the submission on March 10, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K160677 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2016
Decision Date	May 19, 2017
Days to Decision	435 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

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.