IPL Hair Removal Device (YT01,YT02,YT03,YT04)
Shenzhen Jianrong Biomedical Electronics Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Device details
FDA 510(k) registration fields
- K number
- K240016
- Device name
- IPL Hair Removal Device (YT01,YT02,YT03,YT04)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-01-02
- Decision date
- 2024-07-10
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL 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 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 Hair Removal Device (Models: YT01, YT02, YT03, YT04) 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. 550 filter is applied in models YT01 & YT02, 600 filter is applied in model YT03 and 640 filter is applied in model YT04.
Summary parsed at:2026-06-11 04:43:52 UTC
Predicate devices
3IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
K240016 references 3 predicate/reference devices
Cited as predicate
4Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
IPL400
Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
4 submissions cite K240016 as a predicate