IPL Hair Remover, Model: G993, G996, G998 and G885

Shenzhen Mywin Technology Co., Ltd.

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

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
K221679
Device name
IPL Hair Remover, Model: G993, G996, G998 and G885
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-06-09
Decision date
2022-07-07
Submission type
Special
Technology type
IPL(AI inferred)
Clinical applications
FaceBodyOther
Primary application
Body
Classification source
AI classified

Indications for Use

IPL Hair Remover is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Intended Use

IPL Hair Remover is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Device Description

IPL Hair Remover Device (Model: G993, G996, G998 and G885) is an over-the-counter use device for removal of unwanted body and/or facial hair based on Intense Pulsed Light (IPL) treatment. The device package includes IPL DEVICE, Power supply and User manual. It is supplied by AC power supply (Input 100-240 V AC). The weight of the device is 215.1g, and the size is 188 × 76 × 49mm. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device is equipped with a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Remover Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered for pulse emitting. The device can be used for large areas on legs, arms, back and abdomen. The product can flash for 100,000 times.

Summary parsed at:2026-06-11 04:34:18 UTC

Predicate devices

2

K221679 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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