| Primary Device ID | 03664188000145 |
| NIH Device Record Key | b35a7d72-d2dc-4f7a-988a-4cdf53da12f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Visionix VX650 |
| Version Model Number | VX650 |
| Catalog Number | 10005844 |
| Company DUNS | 260432380 |
| Company Name | LUNEAU TECHNOLOGY OPERATIONS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03664188000145 [Primary] |
| HKI | Camera, Ophthalmic, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-16 |
| Device Publish Date | 2023-06-08 |
| 03664188000077 - VISIONIX | 2025-01-10 The VX65 is an automatic phoropter, to measure the subjective refraction, it is used as an ophthalmic device. |
| 03664188000169 - VISIONIX | 2025-01-10 VX90 is an ophthalmic diagnostic device, autorefracto-keratometer |
| 03664188000312 - Luneau | 2025-01-10 Measurement of corneal sensation, specifically tactile. |
| 03664188000435 - ESSILOR | 2025-01-10 Automatic eye-fundus camera and software intended for photographing, displaying,and storing images of the retina without the use |
| 03664188000558 - ESSILOR | 2025-01-10 WAM700+ is a multifunctional eye diagnostic device. |
| 03664188000565 - ESSILOR | 2025-01-10 WAM800 is a multifunctional eye diagnostic device. |
| 03664188000411 - Visionix | 2024-05-08 |
| 03664188000084 - Visionix | 2023-06-23 |