TANDA SKINCARE SYSTEM, MODEL: PTSCS— 510(k) K080591

Substantially Equivalent

Pharos Life Corporation

FDA 510(k) clearance K080591 for TANDA SKINCARE SYSTEM, MODEL: PTSCS, Substantially Equivalent on 2008-11-14. Applicant: Pharos Life Corporation.

Clearance details

Applicant: Pharos Life Corporation
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2008-03-03
Decision date: 2008-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, CA

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.