Cleared Abbreviated

WAVELIGHT FS200 PATIENT INTERFACE 1505

K121031 · Alcon Research, Ltd. · General & Plastic Surgery

Jun 2012

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K121031 is an FDA 510(k) clearance for the WAVELIGHT FS200 PATIENT INTERFACE 1505, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on June 21, 2012, 77 days after receiving the submission on April 5, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K121031 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2012
Decision Date	June 21, 2012
Days to Decision	77 days
Submission Type	Abbreviated
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.