Manufacturer
Iluminage Beauty Co., LimitedHome use hair removal device, model: Precise Touch Pro
Country / Region:Hong Kong (HK)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
- K213830
- Device name
- Home use hair removal device, model: Precise Touch Pro
- Country / Region
- Hong Kong(HK)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-12-08
- Decision date
- 2022-02-01
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- BodyFace
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The Home use hair removal device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Intended Use
The Home use hair removal device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Device Description
The Precise Touch Pro Home use hair removal device 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, AC adapter and device stand three 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 the built-in skin sensor to detect the body skin area. If the device is not properly applied to the expected treatment area (in full contact with the skin), the device cannot be automatic triggered a pulse emitting.
Summary parsed at:2026-06-11 04:30:35 UTC
Predicate devices
2IPL Hair Removal Device Joy Version
IPL Hair removal
K213830 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K213830 as a predicate