The following data is part of a premarket notification filed by Uvision360, Inc. with the FDA for Luminelle Dtx System.
| Device ID | K210512 |
| 510k Number | K210512 |
| Device Name: | LUMINELLE DTx System |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | Uvision360, Inc. 158 Wind Chime Ct. ,Suite #201 Raleigh, NC 27615 |
| Contact | Allison London Brown |
| Correspondent | Rita King MethodSense, Inc. 1 Copley Pkwy, Ste. 410 Morrisville, NC 27560 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-23 |
| Decision Date | 2021-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10853277008098 | K210512 | 000 |
| 10853277008081 | K210512 | 000 |