The following data is part of a premarket notification filed by Li-tek Electronics Technology C0., Ltd with the FDA for Micro-current Facial Cold And Hot Service (model: Tpml-100).
| Device ID | K213039 |
| 510k Number | K213039 |
| Device Name: | Micro-current Facial Cold And Hot Service (model: TPML-100) |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Li-Tek Electronics Technology C0., Ltd No. 8-13, The Industrial Park Of Jinshagang, Shixia Village, Dalang Town Dongguan, CN 523106 |
| Contact | Barry Yuan |
| Correspondent | Jet Li Guangdong Jianda Medical Technology Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-22 |
| Decision Date | 2022-05-25 |