ULTRACUT 2000— 510(k) K960374

Substantially Equivalent

Ultralase Technologies, Inc.

FDA 510(k) clearance K960374 for ULTRACUT 2000, Substantially Equivalent on 1996-06-28. Applicant: Ultralase Technologies, Inc..

Clearance details

Applicant: Ultralase Technologies, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 1996-01-26
Decision date: 1996-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temple City, CA, US

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Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.