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PEACH 2

Foreo AB · Model Peach · UDI-DI 07350120791887

OHSGEX
1
510(k) clearances
107
Adverse events
4
Recalls
131
Facilities

Description

PEACH™ 2 is an over-the-counter device intended for the removal of unwanted body hair and/or facial hair

Recalls

DateFirmReason
2018-06-29Quasar Bio-Tech, Inc.Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2018-06-29Quasar Bio-Tech, Inc.Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2018-06-29Quasar Bio-Tech, Inc.Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2008-06-18Sybaritic, IncSybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.

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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.