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EndyMed PRO MAX, Contour MAX Handpiece

ENDYMED MEDICAL LTD · Model Contour MAX Handpiece · UDI-DI 07290016814477

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510(k) clearances

Adverse events

Recalls

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. The EndyMed Contour MAX Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite.

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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Data 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.