HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE

K913564 · Heraeus Lasersonics, Inc. · GEX · Sep 16, 1991 · General, Plastic Surgery

Device Facts

Record IDK913564
Device NameHERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE
ApplicantHeraeus Lasersonics, Inc.
Product CodeGEX · General, Plastic Surgery
Decision DateSep 16, 1991
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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