DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER— 510(k) K992013

Substantially Equivalent

Continuum Biomedical, Inc.

FDA 510(k) clearance K992013 for DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER, Substantially Equivalent on 1999-09-08. Applicant: Continuum Biomedical, Inc..

Clearance details

Applicant: Continuum Biomedical, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1999-06-15
Decision date: 1999-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.