BRAUN Silk.expert Pro 5

Cyden Limited

Country / region:United Kingdom (GB)Submission type:Special

Product code OHT· 21 CFR 878.4810

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Company

United Kingdom (GB)

Product code

OHT
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

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Device details

FDA 510(k) registration fields

K number
K190354
Device name
BRAUN Silk.expert Pro 5
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

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

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