Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II— 510(k) K043613

Substantially Equivalent

Quantel Medical

FDA 510(k) clearance K043613 for Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II, Substantially Equivalent on 2005-03-24. Applicant: Quantel Medical.

Clearance details

Applicant: Quantel Medical
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2004-12-30
Decision date: 2005-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hot Springs, AR, 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.