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EndyMed PRO MAX, Small MAX Handpiece
ENDYMED MEDICAL LTD · Model Small MAX Handpiece · UDI-DI 07290016814422
PBX
Prescription
10
510(k) clearances
63
Adverse events
1
Recalls
74
Facilities
Description
The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic procedures. When used up to 65W, the Small Max handpiece is also intended for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-07-13 | Bios S.r.l. | In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. |
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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.