OPTOSCALPEL I LASER SYSTEM— 510(k) K923531

Substantially Equivalent

Optomed Corp.

FDA 510(k) clearance K923531 for OPTOSCALPEL I LASER SYSTEM, Substantially Equivalent on 1993-11-12. Applicant: Optomed Corp..

Clearance details

Applicant: Optomed Corp.
Product code: Code HQB
Advisory panel: Ophthalmic
Date received: 1992-07-16
Decision date: 1993-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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.