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EndyMed Pure FSR Handpiece
ENDYMED MEDICAL LTD · Model FSR Handpiece · UDI-DI 07290016814026
OUH
Prescription
5
510(k) clearances
8
Adverse events
1
Recalls
17
Facilities
Description
The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-13 | Aesthetics Biomedical, Inc. | A high frequency output (2 MHz) has not been cleared for distribution in the U.S. |
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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.