Manufacturer
Foreo, Inc.PEACH 2, PEACH 2 Duo, PEACH 2 go
Country / Region:United States (US)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
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
0No predicate K numbers were extracted
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Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K231977 as a predicate