FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEACH 2, PEACH 2 Duo, PEACH 2 go
K Number: K231977
·
Decision Sep 25, 2023
Classifications
1
FEI Numbers
90
Registration Numbers
91
Same Product Code
161
Applicant Total
10
Review Days
84
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Basic Information
- Device Name
- PEACH 2, PEACH 2 Duo, PEACH 2 go
- K Number
- K231977
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Foreo, Inc.
- Date Received
- July 3, 2023
- Decision Date
- September 25, 2023
- Product Code
- OHT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OHT), ordered by most recent decision date.
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
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Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)
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| K240378 | FAQ 201, FAQ 202 | Apr 19, 2024 | Substantially Equivalent |
| K222012 | FAQ 101 | Apr 5, 2023 | Substantially Equivalent |
| K200803 | BEAR and BEAR mini | Jul 31, 2020 | Substantially Equivalent |
| K162450 | ESPADA Acne-Clearing Blue Light Pen | Nov 30, 2016 | Substantially Equivalent |