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PEACH 2, PEACH 2 Duo, PEACH 2 go

Foreo, Inc.

Country / region:United States (US)Submission type:Traditional

Product code OHT· 21 CFR 878.4810

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Company

Foreo, Inc.
United States (US)

Product code

OHT
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K231977
Device name
PEACH 2, PEACH 2 Duo, PEACH 2 go
Company
Foreo, Inc.
Country / region
United States(US)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-07-03
Decision date
2023-09-25
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
BodyFace
Primary application
Body
Classification source
AI classified

Indications for Use

PEACH 2, PEACH 2 Duo and PEACH 2 Go are over-the-counter devices intended for the removal of unwanted body hair and/or facial hair.

Intended Use

PEACH 2, PEACH 2 Duo and PEACH 2 Go are over-the-counter device intended for the removal of unwanted body hair and/or facial hair.

Summary parsed at:2026-06-11 04:41:02 UTC

Predicate devices

0

No predicate K numbers were extracted

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Cited as predicate

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