FDA Device Intelligence
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Fraxis Duo Needle H/P

ILOODA.CO.,LTD · Model FRX 2.0 Needle H/P · UDI-DI 08800023200041

OUHGEI Prescription
1
510(k) clearances
8
Adverse events
1
Recalls
17
Facilities

Description

FRX 2.0 Needle H/P

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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.