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 |