DIAMOND ND:YAG OPHTHALMIC LASER

K901636 · Biovision, Inc. · GEX · Jun 22, 1990 · General, Plastic Surgery

Device Facts

Record IDK901636
Device NameDIAMOND ND:YAG OPHTHALMIC LASER
ApplicantBiovision, Inc.
Product CodeGEX · General, Plastic Surgery
Decision DateJun 22, 1990
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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