Cleared Traditional

Diode Laser Therapy Systems

K191611 · Wingderm Electro-Optics , Ltd. · General & Plastic Surgery

Jul 2019

Decision

44d

Days

Class 2

Risk

About This 510(k) Submission

K191611 is an FDA 510(k) clearance for the Diode Laser Therapy Systems, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Wingderm Electro-Optics , Ltd. (Beijing, CN). The FDA issued a Cleared decision on July 31, 2019, 44 days after receiving the submission on June 17, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K191611 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2019
Decision Date	July 31, 2019
Days to Decision	44 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.