CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE— 510(k) K912987

Name: FDA 510(k) clearance K912987
Creator: U.S. Food and Drug Administration
Published: 1991-10-28

Substantially Equivalent

Douglas James Donaldson Compliance Services

FDA 510(k) clearance K912987 for CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE, Substantially Equivalent on 1991-10-28. Applicant: Douglas James Donaldson Compliance Services. Device class: 2.

Clearance details

Applicant: Douglas James Donaldson Compliance Services
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1991-07-08
Decision date: 1991-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, 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.