MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM

K901340 · Klinger Medical · GEX · Jun 26, 1990 · General, Plastic Surgery

Device Facts

Record IDK901340
Device NameMODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM
ApplicantKlinger Medical
Product CodeGEX · General, Plastic Surgery
Decision DateJun 26, 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
Enter a record ID and click Load to view the document.
100%