Product code HKN
- Device name
- Refractor, Manual, Non-Powered, Including Phoropter
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1770
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06971922132299 | YEASN | Chongqing Yeasn Science & Technology Co.,Ltd. | 2026-05-01 |
| 00628308210480 | Lombart | INNOVA Medical Ophthalmics Inc | 2026-03-31 |
| 00628308210497 | S4Optik | INNOVA Medical Ophthalmics Inc | 2026-03-31 |
| 00628308210503 | Lombart | INNOVA Medical Ophthalmics Inc | 2026-03-31 |
| 00628308210510 | S4Optik | INNOVA Medical Ophthalmics Inc | 2026-03-31 |
| 00628308210527 | Lombart | INNOVA Medical Ophthalmics Inc | 2026-03-31 |
| 00628308210473 | S4Optik | INNOVA Medical Ophthalmics Inc | 2026-03-31 |
| 04987669203552 | Fully Assisted Refraction System | NIDEK CO.,LTD. | 2026-03-27 |
| 00860014277542 | S4 Optik | Lombart Brothers, Inc. | 2025-10-18 |
| 04540008310429 | Rexxam | REXXAM CO., LTD. | 2025-10-17 |
| 00812559010320 | Illuminated Phoropter | REICHERT, INC. | 2025-08-12 |
| 00812559012263 | SightChek Digital Phoropter | REICHERT, INC. | 2025-08-12 |
| 00812559011730 | Phoropter VRx | REICHERT, INC. | 2025-08-12 |
| 00812559011716 | Phoropter VRx | REICHERT, INC. | 2025-08-12 |
| 00812559010290 | Illuminated Phoropter | REICHERT, INC. | 2025-08-12 |
| 00812559010269 | Ultramatic RX Master Phoropter | REICHERT, INC. | 2025-08-12 |
| 00812559010238 | Ultramatic RX Master Phoropter | REICHERT, INC. | 2025-08-12 |
| 00860014277504 | Advancing Eyecare | Lombart Brothers, Inc. | 2025-07-21 |
| 06972039971016 | MOPTIM | Shenzhen CERTAINN Technology Co., Ltd. | 2025-06-23 |
| 06972039971023 | MOPTIM | Shenzhen CERTAINN Technology Co., Ltd. | 2025-06-23 |
| 06972039971214 | MOPTIM | Shenzhen CERTAINN Technology Co., Ltd. | 2025-06-19 |
| 04560126268662 | SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM Chronos | TOPCON CORPORATION | 2025-05-01 |
| 06971922132770 | YEASN | Chongqing Yeasn Science & Technology Co.,Ltd. | 2025-04-08 |
| 04560126268495 | SightPilot NAVi Controller SNi-1 for COMPU VISION CV-5000 | TOPCON CORPORATION | 2025-02-27 |
| 04560126268532 | COMPU VISION CV-5000 | TOPCON CORPORATION | 2025-02-27 |
| 04560126268549 | COMPU VISION CV-5000 | TOPCON CORPORATION | 2025-02-27 |
| 04560126268570 | 1DIAL CONTROLLER KB-50S | TOPCON CORPORATION | 2025-02-27 |
| 04560126268624 | POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE) | TOPCON CORPORATION | 2025-02-27 |
| 00869228000465 | IBEX Manual Refractor | Trevi Technology, Inc. | 2023-01-20 |
| 04987669101445 | REFRACTOR | NIDEK CO.,LTD. | 2019-03-26 |