PBXClass II

Massager, Vacuum, Radio Frequency Induced Heat

General, Plastic Surgery · 21 CFR 878.4400

Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.

MDR events63All time

Recalls1All time

Registered firms151Currently listed

510(k) clearances79All time

Recent MDR events

63 adverse event reports on file

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Event type breakdown

Injury54

Malfunction6

Unspecified3

Most-reported manufacturers

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Cutera, Inc.22 Bios Srl7 Inmode Ltd.6 Cutera, Inc4 Bios S.r.l.3 Candela Corporation3 Syneron Medical Ltd.3 Cutera2

Recalls

1 recall events for this product code

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Bios S.r.l.
TerminatedUnknown
THERMI250 Radiofrequency System.
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
Z-0052-2018 · View FDA record ↗

Registered firms

151 firms currently registered for this product code

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510(k) clearances

79 clearances for this product code

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