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)
FDA 510(k) K250942 · Shenzhen Ulike Smart Electronics Co., Ltd.
510(k) numberK250942
Submission
- Device name
- 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)
- Applicant
- Shenzhen Ulike Smart Electronics Co., Ltd.
Shenzhen, CN - Received
- March 28, 2025
- Decision date
- July 11, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OHT – Light Based Over-The-Counter Hair Removal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.
Other 510(k)s with product code OHT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261705 | Hair Removal Device (R3C16-G Pro, R3C16-V Pro)OHT · Special | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 08/10/2026SE |
| K261325 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…OHT · Special | Shenzhen Ulike Smart Electronics Co., Ltd. | 05/21/2026SE |
| K260594 | IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP…OHT · Traditional | Shenzhen Xiazhifeng Electronic Co., Ltd. | 05/20/2026SE |
| K260742 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…OHT · Traditional | Shenzhen Ulike Smart Electronics Co., Ltd. | 05/05/2026SE |
| K260518 | IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2…OHT · Traditional | Shenzhen Semlamp Intelligent Technology Co., Ltd. | 04/21/2026SE |
| K254047 | Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07…OHT · Traditional | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 03/11/2026SE |
| K253666 | IPL Hair Removal Device (Models: T31A, T32A)OHT · Traditional | Shenzhen Mlay Intelligent Technology Co., Ltd. | 02/23/2026SE |
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD…OHT · Special | Shenzhen Fansizhe Science and Technology Co., Ltd. | 12/29/2025SE |
| K253754 | Philips Lumea IPLOHT · Special | Philips Consumer Lifestyle B.V. | 12/23/2025SE |
| K253304 | IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)OHT · Traditional | Dongguan Lide Electric Appliance Co., Ltd. | 11/25/2025SE |
More from Dongguan Lide Electric Appliance Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261325 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…OHT · Special | 05/21/2026SE |
| K260742 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…OHT · Traditional | 05/05/2026SE |
| K260511 | Ulike Reglow Light Therapy Device (UM10)OHS · Special | 03/16/2026SE |
| K252804 | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR…OHT · Special | 10/01/2025SE |
| K251825 | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)OHS · Traditional | 10/01/2025SE |
| K251984 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…OHT · Special | 07/24/2025SE |
| K250938 | Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01…OHT · Traditional | 05/23/2025SE |
| K243749 | Jmoon Conductive GelGYB · Traditional | 04/08/2025SE |
| K250194 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)OHT · Traditional | 03/26/2025SE |
| K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)NFO · Traditional | 02/03/2025SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K250942) received a 510(k) decision of Substantially Equivalent on July 11, 2025, 105 days after the submission was received.
What is the product code of K250942?
The FDA product code is OHT – Light Based Over-The-Counter Hair Removal, a Class II (moderate risk) device regulated under 21 CFR 878.4810.