FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SmoothSkin Pure
K Number: K200184
·
Decision Feb 21, 2020
Classifications
1
FEI Numbers
90
Registration Numbers
91
Same Product Code
161
Applicant Total
21
Review Days
28
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Basic Information
- Device Name
- SmoothSkin Pure
- K Number
- K200184
- 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
- January 24, 2020
- Decision Date
- February 21, 2020
- 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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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 |
| K192010 | SmoothSkin BARE+ | Sep 24, 2019 | Substantially Equivalent |
| K190354 | BRAUN Silk.expert Pro 5 | Mar 18, 2019 | Substantially Equivalent |
| K190366 | BRAUN Silk Expert Pro 3 | Mar 18, 2019 | Substantially Equivalent |
| K170734 | Venus Silk.expert | May 8, 2017 | Substantially Equivalent |