Cleared Traditional

Dermalux Tri-Wave MD

K200659 · Aesthetic Technology, Ltd. · General & Plastic Surgery

May 2020

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K200659 is an FDA 510(k) clearance for the Dermalux Tri-Wave MD, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Aesthetic Technology, Ltd. (Warrington, GB). The FDA issued a Cleared decision on May 9, 2020, 58 days after receiving the submission on March 12, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K200659 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 2020
Decision Date	May 09, 2020
Days to Decision	58 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.