SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE— 510(k) K113857

Substantially Equivalent

Synergetics, Inc.

FDA 510(k) clearance K113857 for SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE, Substantially Equivalent on 2012-04-23. Applicant: Synergetics, Inc..

Clearance details

Applicant: Synergetics, Inc.
Product code: Code HQB
Advisory panel: Ophthalmic
Date received: 2011-12-30
Decision date: 2012-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: O' Fallon, MO, US

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Adverse events under product code HQB

product code HQB

Other: 2
Total: 2

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.