Manufacturer
Cyden LimitedSmoothSkin Pure Adapt (SSG3)
Country / Region:United Kingdom (GB)Submission type:Special
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K233782
- Device name
- SmoothSkin Pure Adapt (SSG3)
- Company
- Cyden Limited
- Country / Region
- United Kingdom(GB)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-11-27
- Decision date
- 2023-12-20
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Other
- Primary application
- Other
- Classification source
- AI classified
Indications for Use
The SmoothSkin Pure Adapt is intended for the removal of unwanted hair. The SmoothSkin Pure Adapt 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 Adapt is intended for the removal of unwanted hair. The SmoothSkin Pure Adapt 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.
Device Description
The SmoothSkin Pure Adapt is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
Summary parsed at:2026-06-11 04:43:16 UTC
Predicate devices
2—
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Not ingested
SmoothSkin Pure
K233782 references 2 predicate/reference devices
Cited as predicate
1SmoothSkin Pure Switch (SSC1)
1 submission cite K233782 as a predicate
