Manufacturer
Cyden LimitedBRAUN Silk.expert Pro 5
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)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K190354
- Device name
- BRAUN Silk.expert Pro 5
- Company
- Cyden Limited
- Country / Region
- United Kingdom(GB)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-02-15
- Decision date
- 2019-03-18
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- FaceBodyLegsBikini / Brazilian
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The BRAUN Silk.expert Pro 5 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 5 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 BRAUN Silk.expert Pro 5 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 5 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 04:25:40 UTC
Predicate devices
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