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Ibramed Industria Brasileira de Equipamentos Medicos Eir · Model Hooke · UDI-DI 07898966442964

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Hooke is a microcontrolled, non-ablative, high frequency radiofrequency equipment (27.12MHz), which can be used in the areas of facial and body aesthetics. The equipment has four applicators: three radiofrequency applicators, FACIAL (small bipolar applicator), BIPOLAR (body bipolar applicator) and MONOPOLAR (body monopolar applicator) and a COOLING applicator (air-cooled) for thermal comfort and preservation of the epidermis.

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.