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IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)

Dongguan Boyuan Intelligent Technology Co.,Ltd

Country / region:China (CN)Submission type:Traditional

Product code OHT· 21 CFR 878.4810

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Company

Dongguan Boyuan Intelligent Technology Co.,Ltd
China (CN)

Product code

OHT
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K240282
Device name
IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)
Company
Dongguan Boyuan Intelligent Technology Co.,Ltd
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-02-01
Decision date
2024-04-03
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyLegsBikini / BrazilianUnderarm
Primary application
Body
Classification source
AI classified

Indications for Use

IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device 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

IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device 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 04:44:35 UTC

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