Manufacturer
Shenzhen Shuge Medical Beauty Devices Co., Ltd.IPL Home Use Hair Removal Device (SJ15)
Shenzhen Shuge Medical Beauty Devices 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
- K240093
- Device name
- IPL Home Use Hair Removal Device (SJ15)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-01-12
- Decision date
- 2024-04-24
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL Home Use Hair Removal Device 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.
Intended Use
IPL Home Use Hair Removal Device 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
IPL Home Use Hair Removal Device (Model:SJ15) is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL) to emit a specific wavelength of the light ranging from 550-1200nm and delivers to the skin. The device is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy (below the surface of the skin), which disables the hair follicle preventing further growth, so as to achieve effective hair removal.
Summary parsed at:2026-06-11 04:44:08 UTC
Predicate devices
2IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
K240093 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 K240093 as a predicate
