SHARPLAN 743, CO2 LASER SURGICAL SYSTEM

K792418 · Laser Industries , Ltd. · GEX · Feb 5, 1980 · General, Plastic Surgery

Device Facts

Record IDK792418
Device NameSHARPLAN 743, CO2 LASER SURGICAL SYSTEM
ApplicantLaser Industries , Ltd.
Product CodeGEX · General, Plastic Surgery
Decision DateFeb 5, 1980
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4810
Device ClassClass 2

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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