| Primary Device ID | 08800019600954 |
| NIH Device Record Key | 074de22e-faf7-4205-b5a1-adac4d4121b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vision Screener |
| Version Model Number | HVS-1 |
| Company DUNS | 688154202 |
| Company Name | Huvitz Co., Ltd. |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800019600954 [Primary] |
| HKO | Refractometer, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-23 |
| Device Publish Date | 2026-02-13 |
| 08800019600954 - Vision Screener | 2026-02-23The HVS-1 is a hand-held Vision Screener designed to measure the refractive power of the eye, providing Sphere (SPH), Cylinder (CYL), and Axis (AXS) data, as well as Pupillary Distance (PD) and pupil size. |
| 08800019600954 - Vision Screener | 2026-02-23 The HVS-1 is a hand-held Vision Screener designed to measure the refractive power of the eye, providing Sphere (SPH), Cylinder ( |
| 08800019600992 - Auto Ref-Topographer HRKT-1 | 2026-02-09 The Auto Ref-Topographer HRKT-1 measures the light reflected from the retina using an MLA (Micro Lens Array) to provide informat |
| 08800019601005 - Lilivis | 2025-09-16 The Huvitz Dental Intraoral Scanner(LS-100) is a dental 3D scanner intended to be used to digitally record topographical charact |
| 08800019600794 - Huvitz Integrated Image Server HIIS-1 | 2025-08-22 This software (HIIS-1) is a web-based software that can store, analyze, print and transmit the medical images and refraction dat |
| 08800019600961 - OCTiX IntraOral Scanner | 2025-03-26 Huvitz Dental Intraoral Scanner OCT (LSO-100) is a dental 3D scanner intended to be used to digitally record topographical chara |
| 00880019600961 - Lilivis SCAN OPTOMO | 2024-12-04 Huvitz Dental Intraoral Scanner OCT (LSO-100) is a dental 3D scanner intended to be used to digitally record topographical chara |
| 08800019600978 - Instrument Table CIT-4100 | 2024-07-02 Instrument Table CIT-4100 |
| 08800019600985 - Instrument Table CIT-4200 | 2024-07-02 Instrument Table CIT-4200 |