SPPHINE PLUS STM 3W DIODE LASER— 510(k) K110079

Substantially Equivalent

Den-Mat Holdings, LLC

FDA 510(k) clearance K110079 for SPPHINE PLUS STM 3W DIODE LASER, Substantially Equivalent on 2011-02-10. Applicant: Den-Mat Holdings, LLC.

Clearance details

Applicant: Den-Mat Holdings, LLC
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2011-01-11
Decision date: 2011-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

Download summary PDF View on FDA.gov ↗

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.