Cleared Special

WaveLight FS200 Patient Interface

K190392 · Alcon Laboratories, Inc. · Ophthalmic

Mar 2019

Decision

35d

Days

Class 2

Risk

About This 510(k) Submission

K190392 is an FDA 510(k) clearance for the WaveLight FS200 Patient Interface, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Alcon Laboratories, Inc. (Lake Forest, US). The FDA issued a Cleared decision on March 26, 2019, 35 days after receiving the submission on February 19, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K190392 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2019
Decision Date	March 26, 2019
Days to Decision	35 days
Submission Type	Special
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.