MODEL 2000 OPHTHALMIC SURGICAL SYSTEM— 510(k) K940084

Substantially Equivalent

Medical Technical Products

FDA 510(k) clearance K940084 for MODEL 2000 OPHTHALMIC SURGICAL SYSTEM, Substantially Equivalent on 1994-06-17. Applicant: Medical Technical Products.

Clearance details

Applicant: Medical Technical Products
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1994-01-07
Decision date: 1994-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, US

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Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.