IPL hair removal

Shenzhen Lizbella Technology Co.,Ltd

Country / region:China (CN)Submission type:Traditional

Product code OHT· 21 CFR 878.4810

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Product code

OHT
21 CFR 878.4810

Predicate devices

2

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

K221451 references 2 predicate/reference devices

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0

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