OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY— 510(k) K050541

Name: FDA 510(k) clearance K050541
Creator: U.S. Food and Drug Administration
Published: 2005-05-09

Substantially Equivalent

Omniguide Communications, Inc.

FDA 510(k) clearance K050541 for OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY, Substantially Equivalent on 2005-05-09. Applicant: Omniguide Communications, Inc.. Device class: 2.

Clearance details

Applicant: Omniguide Communications, Inc.
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
Advisory panel: Ophthalmic
Date received: 2005-03-02
Decision date: 2005-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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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.