APLION TOPICAL CARE SYSTEM— 510(k) K091133

Substantially Equivalent

Aplion Medical,Llc

FDA 510(k) clearance K091133 for APLION TOPICAL CARE SYSTEM, Substantially Equivalent on 2009-05-20. Applicant: Aplion Medical,Llc.

Clearance details

Applicant: Aplion Medical,Llc
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 2009-04-20
Decision date: 2009-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.