The following data is part of a premarket notification filed by Uvbiotek, Llc with the FDA for Led Light Therapy Device.
| Device ID | K180900 |
| 510k Number | K180900 |
| Device Name: | LED Light Therapy Device |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Uvbiotek, LLC 3 Depot Street, Hudson Falls New York, NY 12839 |
| Contact | Dave Oberhelman |
| Correspondent | Jinghua Zhou Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, CN 511660 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-06 |
| Decision Date | 2018-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3437000CA1 | K180900 | 000 |