UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER— 510(k) K931774

Substantially Equivalent

Sunrise Technologies, Inc.

FDA 510(k) clearance K931774 for UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER, Substantially Equivalent on 1993-07-22. Applicant: Sunrise Technologies, Inc..

Clearance details

Applicant: Sunrise Technologies, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1993-04-09
Decision date: 1993-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, 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.