Manufacturer
Shenzhen Desida Technology Co., Ltd.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
Product code
OHT
21 CFR 878.4810
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—
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Not ingested
Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
IPL Home Use Hair Removal Device
K221635 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K221635 as a predicate