4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER

K881619 · Heraeus Lasersonics, Inc. · GEX · Jul 8, 1988 · General, Plastic Surgery

Device Facts

Record IDK881619
Device Name4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER
ApplicantHeraeus Lasersonics, Inc.
Product CodeGEX · General, Plastic Surgery
Decision DateJul 8, 1988
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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