DIPLOMAX— 510(k) K946054

Substantially Equivalent

Optical Micro Systems, Inc.

FDA 510(k) clearance K946054 for DIPLOMAX, Substantially Equivalent on 1995-07-11. Applicant: Optical Micro Systems, Inc..

Clearance details

Applicant: Optical Micro Systems, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1994-12-12
Decision date: 1995-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Andover, MA, US

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Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.