Leaf Smooth
FDA 510(k) K212697 · Shenzhen Leaflife Technology Co., Ltd.
510(k) numberK212697
Submission
- Device name
- Leaf Smooth
- Applicant
- Shenzhen Leaflife Technology Co., Ltd.
Shenzhen, CN - Received
- August 25, 2021
- Decision date
- November 19, 2021
- 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 |
|---|---|---|
| K253219 | LeafPure-Echo (LM-LPNdA)GEX · Traditional | 11/25/2025SE |
| K250916 | WinForth (LM-E470KA)PBX · Traditional | 08/14/2025SE |
| K233760 | Mjolnir Pro. (Multielectrode plasma)QVJ · Traditional | 02/20/2024SE |
| K230362 | Planar LED mateOHT · Traditional | 09/11/2023SE |
| K220103 | LED Therapy Device (Planar LED/Planar LED mini)GEX · Traditional | 04/12/2022SE |
| K202980 | Laser Therapy DeviceGEX · Traditional | 11/19/2020SE |
Questions and answers
When was Leaf Smooth cleared by the FDA?
Leaf Smooth (K212697) received a 510(k) decision of Substantially Equivalent on November 19, 2021, 86 days after the submission was received.
What is the product code of K212697?
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.