IPL sapphire ice cooling hair remove device

Shenzhen Desida 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

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K221635
Device name
IPL sapphire ice cooling hair remove device
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-06-06
Decision date
2022-08-31
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
Body
Primary application
Body
Classification source
AI classified

Indications for Use

IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.

Intended Use

IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.

Device Description

The IPL sapphire cooling hair remove 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 device is only powered by the external 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.

Summary parsed at:2026-06-11 04:33:58 UTC

Predicate devices

3

K221635 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K221635 as a predicate