Manufacturer
Lumenessa CorpIPL hair removal device
Country / Region:United States (US)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
- K232274
- Device name
- IPL hair removal device
- Company
- Lumenessa Corp
- Country / Region
- United States(US)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-07-31
- Decision date
- 2023-09-28
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceBody
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The product is an over-the-counter device intended for removal of unwanted body and facial hair.
Intended Use
The product is an over-the-counter device intended for removal of unwanted body and facial hair.
Device Description
IPL 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. 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 lamp and a skin tone 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 be triggered a pulse emitting. The IPL hair removal device includes LS101 and LS102 two models. Their intended use, performance, structure design and operation are identical, with the different color of grip part. The difference does not affect or change the intended use of the device.
Summary parsed at:2026-06-11 04:42:11 UTC