LAZERSMILE, LAZERWHITE— 510(k) K000290

Substantially Equivalent

Biolase Technology, Inc.

FDA 510(k) clearance K000290 for LAZERSMILE, LAZERWHITE, Substantially Equivalent on 2000-04-14. Applicant: Biolase Technology, Inc..

Clearance details

Applicant: Biolase Technology, Inc.
Product code: Code EFW
Advisory panel: Dental
Date received: 2000-01-31
Decision date: 2000-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clemente, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

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.