ONDA PRO

DEKA M.E.L.A. SRL · Model M116V1 · UDI-DI 08034108513270

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The ONDA PRO is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a 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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.