The following data is part of a premarket notification filed by Uvbiotek, Llc with the FDA for Photodynamic Therapy Device.
| Device ID | K170187 |
| 510k Number | K170187 |
| Device Name: | Photodynamic Therapy Device |
| Classification | Powered Laser Surgical Instrument |
| Applicant | UVBIOTEK, LLC 3 Depot Street Hudson Falls, NY 12839 |
| Contact | Dave Oberhelman |
| Correspondent | Zhou Jinghua Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, CN 511660 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-23 |
| Decision Date | 2017-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3437000A1 | K170187 | 000 |