DM001 DISPOSABLE PACK— 510(k) K953539

Substantially Equivalent

American Optisurgical, Inc.

FDA 510(k) clearance K953539 for DM001 DISPOSABLE PACK, Substantially Equivalent on 1995-12-26. Applicant: American Optisurgical, Inc..

Clearance details

Applicant: American Optisurgical, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1995-07-28
Decision date: 1995-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.