The following data is part of a premarket notification filed by Li-tek Electronic Technology Corporation with the FDA for Led Phototherapy Device.
| Device ID | K162098 |
| 510k Number | K162098 |
| Device Name: | LED Phototherapy Device |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | LI-TEK ELECTRONIC TECHNOLOGY CORPORATION NO.8-13, THE INDUSTRIAL PARK OF JINSHAGANG, SHIXIAVILLAGE, DALANGTOWN Dongguan, CN |
| Contact | Barry Yuan |
| Correspondent | Jet Li GUANGZHOU LETA TESTING TECHNOLOGY CO.,LTD 6F, NO.1 TIAN TAI 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 | 2016-07-29 |
| Decision Date | 2017-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00031262096265 | K162098 | 000 |