Manufacturer
Gu'An Yeolight Smart Electronics Co., Ltd.IPL Hair Removal Device (SYL001AZ, SYL002AZ)
Gu'An Yeolight Smart Electronics 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
- K253035
- Device name
- IPL Hair Removal Device (SYL001AZ, SYL002AZ)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-09-22
- Decision date
- 2025-11-19
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceBodyOther
- 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 and/or facial hair.
Intended Use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.
Device Description
The IPL Hair Removal 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 main unit, power adapter and protective goggles. The device contains a skin sensor to detect appropriate skin contact; if the light emitting window is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature by the Sapphire and provide the user with a better using experience. There are SYL001AZ and SYL002AZ two models in this application. Their work principle, function, intended use, structure, appearance and composition are the same, with the only difference in treatment level.
Summary parsed at:2026-06-11 04:32:34 UTC
Predicate devices
2IPL Hair Removal, Model: OBT-02
IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
K253035 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K253035 as a predicate
