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Skin Resurfacing Rf Applicator

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

78
Registered devices
8
Adverse events
1
Recalls
5
510(k) clearances

Devices with this code

VIVACE ULTRA — Aesthetics Biomedical, Inc.INTRAgen Tip — Jeisys Medical Inc.Fraxis Duo Main Unit — CLASSYS Inc.Fraxis Duo 25Pin Needle Tip — CLASSYS Inc.Fraxis Duo Articulated arm — CLASSYS Inc.VIVACE ULTRA — Aesthetics Biomedical, Inc.INTRAgen — Jeisys Medical Inc.Fraxis Duo ARM — ILOODA.CO.,LTDSecret PRO Bigger Handpiece — CLASSYS Inc.Max-M25 — CLASSYS Inc.EndyMed Pro Small Handpiece — ENDYMED MEDICAL LTDSecret RF Small H/P — ILOODA.CO.,LTDFraxis Duo 25Pin Needle Tip — ILOODA.CO.,LTDVIVACE ULTRA — Aesthetics Biomedical, Inc.Max-64C — CLASSYS Inc.VIVACE ULTRA — Aesthetics Biomedical, Inc.Secret RF Smartcure — ILOODA.CO.,LTDVIVACE Electrosurgical System — shenb Co., Ltd.QUADESSY Deeplus hand piece — CLASSYS Inc.Max-25 — CLASSYS Inc.Secret RF Smartcure Applicator With Electrodes — CLASSYS Inc.EndyMed Pro FSR Handpiece — ENDYMED MEDICAL LTDVIVACE ULTRA — Aesthetics Biomedical, Inc.Virtue RF Microneedle Cartridge — shenb Co., Ltd.

Recent recalls

DateFirmReason
2020-03-13Aesthetics Biomedical, Inc.A high frequency output (2 MHz) has not been cleared for distribution in the U.S.

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