Manufacturer
Cyden LimitedSmoothSkin Pure Unplugged (SSB3)
Country / Region:United Kingdom (GB)Submission type:Special
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K240587
- Device name
- SmoothSkin Pure Unplugged (SSB3)
- Company
- Cyden Limited
- Country / Region
- United Kingdom(GB)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-03-01
- Decision date
- 2024-03-29
- Submission type
- Special
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The SmoothSkin Pure Unplugged is intended for the removal of unwanted hair. The SmoothSkin Pure Unplugged 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 Unplugged is intended for the removal of unwanted hair. The SmoothSkin Pure Unplugged 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 Unplugged is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is battery powered and charged by mains. The device consists of the handset with removal battery pack, Handset Dock station, and AC Adapter. AC mains is fed to the AC Adapter and converted to DC to charge the battery pack via the docking station contact pins, the device cannot be used when charging. The battery pack 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 04:45:02 UTC
Predicate devices
1SmoothSkin Pure Mini
K240587 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K240587 as a predicate
