FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SmoothSkin BARE+
K Number: K192010
·
Decision Sep 24, 2019
Classifications
1
FEI Numbers
94
Registration Numbers
95
Same Product Code
141
Applicant Total
10
Review Days
57
Basic Information
- Device Name
- SmoothSkin BARE+
- K Number
- K192010
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CyDen Limited
- Date Received
- July 29, 2019
- Decision Date
- September 24, 2019
- 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
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Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
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Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
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Other Clearances by CyDen Limited
| K Number | Device Name | ||
|---|---|---|---|
| K243362 | SmoothSkin Pure Switch (SSC1) | Nov 27, 2024 | Substantially Equivalent |
| K240587 | SmoothSkin Pure Unplugged (SSB3) | Mar 29, 2024 | Substantially Equivalent |
| K233782 | SmoothSkin Pure Adapt (SSG3) | Dec 20, 2023 | Substantially Equivalent |
| K230911 | Braun Skin i.expert | Apr 27, 2023 | Substantially Equivalent |
| K213692 | SmoothSkin Pure Mini | Jan 26, 2022 | Substantially Equivalent |
| K211994 | Braun Silk.expert Mini | Jul 28, 2021 | Substantially Equivalent |
| K200184 | SmoothSkin Pure | Feb 21, 2020 | Substantially Equivalent |
| K190354 | BRAUN Silk.expert Pro 5 | Mar 18, 2019 | Substantially Equivalent |
| K190366 | BRAUN Silk Expert Pro 3 | Mar 18, 2019 | Substantially Equivalent |