Manufacturer
Shenzhen Borria Technology Co., Ltd.IPL hair removal machine
Shenzhen Borria Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
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
- K213020
- Device name
- IPL hair removal machine
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-09-20
- Decision date
- 2021-12-16
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceUnderarmLegsOther
- Primary application
- Legs
- Classification source
- AI classified
Indications for Use
IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
Intended Use
IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
Device Description
The BR2020 IPL hair removal machine is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the treatment window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse.
Summary parsed at:2026-06-11 04:29:27 UTC
Predicate devices
3—
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Not ingested
IPL Hair removal
Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
K213020 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K213020 as a predicate