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Ibramed Industria Brasileira de Equipamentos Medicos Eir · Model Cryotecar · UDI-DI 07898966442933

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The CRYOTECAR equipment is designed for therapies including Tecartherapy, Radiofrequency, Cryotecartherapy, Cryofrequency, and Fractional techniques. These non-invasive treatments use capacitive and resistive applicators to promote tissue heating, aiding in the temporary improvement of sagging skin, cellulite, and localized fat. Cryotecartherapy and Cryofrequency feature cooled tips for a more comfortable temperature increase. The device supports monopolar and bipolar modes, with capacitive tips for superficial heating and resistive tips for deeper tissue treatment. Fractional Cryofrequency and Radiofrequency create microscopic thermal lesions, enhancing skin tightening in facial and body aesthetics.

Recalls

Date	Firm	Reason
2011-11-15	Biomet Microfixation, LLC	On 11/15/2011 Biomet Microfixation, Jacksonville, FL initiated a recall of their Acticort Heat/Contouring Pen, Model #915-3100, Lot #861200. Product is incorrectly labeled

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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.