| Primary Device ID | 08034028770609 |
| NIH Device Record Key | 22833a30-6a94-4bbc-805d-b8c397ed8c81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TERA Dry Eye Imager |
| Version Model Number | TERA Dry Eye Imager |
| Catalog Number | 42-0002941US |
| Company DUNS | 447668039 |
| Company Name | VISIA IMAGING SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 | 08034028770609 [Primary] |
| MMQ | Topographer, Corneal, 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 | 2025-08-14 |
| Device Publish Date | 2025-08-06 |
| 08034028770609 - TERA Dry Eye Imager | 2025-08-14 |
| 08034028770609 - TERA Dry Eye Imager | 2025-08-14 |
| 08034028770524 - TOPCON | 2025-02-28 SOLOS Lite is an instrument intended for use by an optometric/ ophthalmic professional to monitor the visual defects through the |
| 08034028770562 - TOPCON | 2025-02-28 instrument intended for use by an optometric/ ophthalmic professional for the analysis of visual acuity |
| 08034028770517 - ESSILOR | 2024-11-12 BIOMETER - TOPOGRAPHER |
| 08034028770487 - MYAH | 2023-10-20 |
| 08034028770470 - SeeNA | 2023-06-05 INTEGRATED DEVICE OCULAR BIOMETER AND CORNEAL ANALYZER |
| 08034028770463 - MYOPIA EXPERT 700 | 2022-06-30 BIOMETER - TOPOGRAPHER |
| 08034028770456 - MYAH | 2022-06-22 |