IPL Hair Removal Device

Shenzhen Goodwind Technology Development Co., Ltd.

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

Product code OHT· 21 CFR 878.4810

View Summary PDF

Product code

OHT
21 CFR 878.4810

Predicate devices

1

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K222316
Device name
IPL Hair Removal Device
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-08-02
Decision date
2022-09-28
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyOther
Primary application
Body
Classification source
AI classified

Indications for Use

The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.

Intended Use

The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.

Device Description

The 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, 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 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 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. Also, the subject device is equipped with ice compress function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use. The IPL Hair Removal Device includes ZHF-IPL-II and ZHF-IPL-III two models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly in product appearance and its spot size of the treatment window, output energy, and display form, but these differences do not affect or change the intended use of the device. The model difference is embodied in #1) the spot size of the ZHF-IPL-II is 3.6cm² and the corresponding output energy is 2.6~4.4J/cm²; the spot size of the ZHF-IPL-III is 4.1cm² and the corresponding output energy is 2.4~3.7J/cm²; #2) the display form of ZHF-IPL-II is LCD display screen and indicator light, and the display form of ZHF-IPL-III is indicator bar and light.

Summary parsed at:2026-06-11 04:34:32 UTC

Predicate devices

1

K222316 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K222316 as a predicate