MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.

K871029 · Directed Energy, Inc. · LNK · May 18, 1987 · General, Plastic Surgery

Device Facts

Record IDK871029
Device NameMODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.
ApplicantDirected Energy, Inc.
Product CodeLNK · General, Plastic Surgery
Decision DateMay 18, 1987
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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