MODEL MC 1100 SURGICAL YAG LASER— 510(k) K903943

Substantially Equivalent

Klinger Micro-Controle Group

FDA 510(k) clearance K903943 for MODEL MC 1100 SURGICAL YAG LASER, Substantially Equivalent on 1990-11-21. Applicant: Klinger Micro-Controle Group.

Clearance details

Applicant: Klinger Micro-Controle Group
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1990-08-27
Decision date: 1990-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mission Viejo, CA, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.