The following data is part of a premarket notification filed by Uvision360 Inc. with the FDA for Luminelle Dtx Hysteroscopy System.
| Device ID | K181909 |
| 510k Number | K181909 |
| Device Name: | Luminelle DTx Hysteroscopy System |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | UVision360 Inc. 4441-106 Six Forks Road, #179 Raleigh, NC 27609 |
| Contact | Allison London Brown |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-07-17 |
| Decision Date | 2018-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853227708040 | K181909 | 000 |
| 00853277008015 | K181909 | 000 |
| 00853277008022 | K181909 | 000 |
| 00853277008039 | K181909 | 000 |
| 00853277008046 | K181909 | 000 |
| 00853227708002 | K181909 | 000 |
| 00853227708019 | K181909 | 000 |
| 00853227708026 | K181909 | 000 |
| 00853227708033 | K181909 | 000 |
| 00853277008008 | K181909 | 000 |