The following data is part of a premarket notification filed by Enlightenvue, Inc. with the FDA for Enlightenvue Microendoscopy System.
| Device ID | K192300 |
| 510k Number | K192300 |
| Device Name: | EnlightenVue Microendoscopy System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | EnlightenVue, Inc. 1111 Race Street, Suite 6a Denver, CO 80206 |
| Contact | Giacomo Basadonna |
| Correspondent | Giacomo Basadonna Alira Health 1111 Race Street Suite 6a Denver, CO 80206 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-23 |
| Decision Date | 2020-03-20 |