Manufacturer
Shenzhen Century Dongyuan Technology CO , Ltd.IPL Hair Removal Device, model: AI01
Shenzhen Century Dongyuan Technology CO , Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K212897
- Device name
- IPL Hair Removal Device, model: AI01
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-09-10
- Decision date
- 2021-11-04
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- Body
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The IPL Hair Removal Device (Model: AI01) is intended for the removal of unwanted body hair.
Intended Use
The IPL Hair Removal Device (Model: AI01) is intended for the removal of unwanted body hair.
Device Description
IPL Hair Removal Device, model: AI01 is a device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon Arc Flashlamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. Device includes a main unit, an adaptor, and accessories, accessories include goggle. Principle of operation: The device works by use of thermal energy of Intense Pulse Light (IPL) to kill hair follicles for hair removal. The device generally targets skin (including dermis, epidermis), underlying soft tissue and hair follicles.
Summary parsed at:2026-06-11 04:29:12 UTC
Predicate devices
1IPL Hair Removal Device
K212897 references 1 predicate/reference device
Cited as predicate
1IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
1 submission cite K212897 as a predicate