K231977
- 510(k) number
- K231977
- Device name
- PEACH 2, PEACH 2 Duo, PEACH 2 go
- Applicant
- Foreo, Inc. NV · US
- Product code
- OHT — Light Based Over-The-Counter Hair Removal
- Decision date
- 2023-09-25
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231977
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.