OPHALMIC LASER PHOTOCOAGULATOR— 510(k) K854288

Substantially Equivalent

Mira, Inc.

FDA 510(k) clearance K854288 for OPHALMIC LASER PHOTOCOAGULATOR, Substantially Equivalent on 1985-11-12. Applicant: Mira, Inc..

Clearance details

Applicant: Mira, Inc.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1985-10-25
Decision date: 1985-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

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.