Braun Skin i.expert

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

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Device details

FDA 510(k) registration fields

K number
K230911
Device name
Braun Skin i.expert
Country / region
United Kingdom(GB)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-03-31
Decision date
2023-04-27
Submission type
Special

Indications for Use

The Braun Skin i.expert Hair Removal Device is indicated for the removal of unwanted hair. The Braun Skin i.expert 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 Skin i.expert Hair Removal Device is indicated for the removal of unwanted hair. The Braun Skin i.expert 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 04:39:49 UTC

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