Cleared Special

SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

K211401 · Gyrus Acmi, Inc. · General & Plastic Surgery

Jun 2021

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K211401 is an FDA 510(k) clearance for the SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories), a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Gyrus Acmi, Inc. (Westborough, US). The FDA issued a Cleared decision on June 3, 2021, 28 days after receiving the submission on May 6, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K211401 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2021
Decision Date	June 03, 2021
Days to Decision	28 days
Submission Type	Special
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.