Manufacturer
Shenzhen Greatro Electronic Technology Co., Ltd.Intense Pulse Light Therapeutic Apparatus
Shenzhen Greatro Electronic 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
- K232932
- Device name
- Intense Pulse Light Therapeutic Apparatus
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-09-20
- Decision date
- 2023-12-04
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- Body
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.
Intended Use
Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.
Device Description
The Intense Pulse Light Therapeutic Apparatus 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, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The Intense Pulse Light Therapeutic Apparatus is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. There are IPL-1 PRO, IPL-1, IPL-12, and IPL-17 four models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, size are slight differences, but these parameters are within the
Summary parsed at:2026-06-11 04:42:53 UTC
Predicate devices
2IPL HAIR REMOVAL HANDSET, Model: IPL-666
IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
K232932 references 2 predicate/reference devices
Cited as predicate
2IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
2 submissions cite K232932 as a predicate