Manufacturer
Shenzhen Huachuangtong Industrial Co., Ltd.IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
Shenzhen Huachuangtong Industrial 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
- K251707
- Device name
- IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-06-03
- Decision date
- 2025-08-01
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair. Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair. Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. Applicable skin Fitzpatrick skin types I-V.
Intended Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair. Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair. Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
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 its built-in 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. There are HCT-1208/HCT-1208B/HCT-1208L 3 models in this application. Their work principle, intended use, structure, appearance, size, and operation are the same, with differences being product function are slight differences, but these parameters are within the
Summary parsed at:2026-06-11 04:30:43 UTC
Predicate devices
2Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
K251707 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 K251707 as a predicate
