Manufacturer
Cyden LimitedSmoothSkin Pure Mini
Country / Region:United Kingdom (GB)Submission type:Special
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Device details
FDA 510(k) registration fields
- K number
- K213692
- Device name
- SmoothSkin Pure Mini
- Company
- Cyden Limited
- Country / Region
- United Kingdom(GB)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-11-23
- Decision date
- 2022-01-26
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The SmoothSkin Pure Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure Mini is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Intended Use
The SmoothSkin Pure Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure Mini is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Summary parsed at:2026-06-11 04:30:24 UTC
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
1SmoothSkin Pure Unplugged (SSB3)
1 submission cite K213692 as a predicate