Cleared Traditional

Vitra 2

K191962 · Quantel Medical · Ophthalmic

Dec 2019

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K191962 is an FDA 510(k) clearance for the Vitra 2, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Quantel Medical (Cournon D' Auvergne-Cedex, FR). The FDA issued a Cleared decision on December 5, 2019, 135 days after receiving the submission on July 23, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K191962 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2019
Decision Date	December 05, 2019
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
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.