Cleared Traditional

MEDILASER-S MEL-444-S

K840739 · Mochida Pharmaceutical Co., Ltd. · General & Plastic Surgery

Sep 1984

Decision

212d

Days

Class 2

Risk

About This 510(k) Submission

K840739 is an FDA 510(k) clearance for the MEDILASER-S MEL-444-S, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Mochida Pharmaceutical Co., Ltd. (Walker, US). The FDA issued a Cleared decision on September 20, 1984, 212 days after receiving the submission on February 21, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K840739 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 1984
Decision Date	September 20, 1984
Days to Decision	212 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

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.