NLITE SYSTEM, SLS MODEL NUMBER A00-1025— 510(k) K000811

Substantially Equivalent

Sls Biophile , Ltd.

FDA 510(k) clearance K000811 for NLITE SYSTEM, SLS MODEL NUMBER A00-1025, Substantially Equivalent on 2000-08-25. Applicant: Sls Biophile , Ltd..

Clearance details

Applicant: Sls Biophile , Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2000-03-13
Decision date: 2000-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Llanelli, GB

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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.