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POWERX
SOLTA MEDICAL · Model 115-0018 · UDI-DI 00850608002575
QPB
Prescription
10
510(k) clearances
69
Adverse events
1
Recalls
48
Facilities
Description
ACCESSORY KIT, POWERX SYSTEM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-18 | HUMAN MED AG | The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spra |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.