EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG

K922375 · Excel Tech. , Ltd. · GEX · Jul 8, 1992 · General, Plastic Surgery

Device Facts

Record IDK922375
Device NameEXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG
ApplicantExcel Tech. , Ltd.
Product CodeGEX · General, Plastic Surgery
Decision DateJul 8, 1992
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

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