Ophthalmed Bending Laser Probes— 510(k) K142830

Substantially Equivalent

Ophthalmed, LLC

FDA 510(k) clearance K142830 for Ophthalmed Bending Laser Probes, Substantially Equivalent on 2015-06-25. Applicant: Ophthalmed, LLC.

Clearance details

Applicant: Ophthalmed, LLC
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2014-09-30
Decision date: 2015-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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.