Manufacturer
Shenzhen Lizbella Technology Co.,LtdIPL hair removal
Shenzhen Lizbella 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
- K221451
- Device name
- IPL hair removal
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-05-18
- Decision date
- 2022-08-01
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL hair removal is an over-the-counter device intended for removal of unwanted body hair.
Intended Use
IPL hair removal is an over-the-counter device intended for removal of unwanted body hair.
Device Description
The IPL hair removal 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 IPL hair removal 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 sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the light pulse. The IPL hair removal includes FZ-610, FZ-609, FZ-612, FZ-611, FZ-613, and FZ-608 six models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains product appearance and its spot size of the treatment window, but these differences do not affect or change the intended use of the device.
Summary parsed at:2026-06-11 04:33:05 UTC
Predicate devices
2—
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Not ingested
IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
K221451 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 K221451 as a predicate