FDA Device Intelligence
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Massager, Vacuum, Radio Frequency Induced Heat

FDA product code PBX · Class 2 · General, Plastic Surgery

282
Registered devices
63
Adverse events
1
Recalls
79
510(k) clearances

Devices with this code

Face Applicator (Cheek Left ) — INMODE M.D LTDVenus Legacy 110V - Nikao — VENUS CONCEPT LTDPELLEFIRM Handpiece — Cynosure, LLCMIRARI Cold Plasma unit box set — General Vibronics, LLCExilis small applicator — BTL INDUSTRIES LIMITEDInBellaBody System — Inbella Medical IncHuman Tecar — UNIBELL SRLFormaI — INMODE M.D LTDEMTONE — BTL INDUSTRIES LIMITEDBelt Bliss — VENUS CONCEPT LTDCOMPACT PLUS — INDIBA SA.Human Tecar — UNIBELL SRLSUPERCHARGE HYDRA FASCIA ELECTRODES — UNIBELL SRLFlexSure Large Applicator 10-Pack — Cynosure, LLCHuman Tecar — UNIBELL SRLTIAC 1 — EL.EN. SPAVenus Legacy kit — VENUS CONCEPT LTDHuman Tecar — UNIBELL SRLBTL-785F — BTL INDUSTRIES LIMITEDINDIBA DEEP CARE - PREMIUM — INDIBA SA.ASSY, Probe, Single, TempSure Vitalia — Cynosure, LLCChin Applicator — INMODE M.D LTDBODY LASER APPLICATOR BLISS — VENUS CONCEPT LTDHuman Tecar — UNIBELL SRL

Recent recalls

DateFirmReason
2017-07-13Bios S.r.l.In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.