Product code HKL
- Device name
- Retinoscope, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1780
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K001111 | PANORET, MODEL 1000A | Cmt Medical Technologies, Ltd. | 2000-07-07 |
| K950789 | STREAK RETINOSCOPE RX-1 | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K950790 | STREAK RETINOSCOPE RX-2 | Neitz Instruments Company, Ltd. | 1995-03-22 |
| K893171 | VISTA STREAK RETINOSCOPE (AC-POWERED) | Keeler Instruments, Inc. | 1989-09-21 |
| K812764 | KOI BLUE FIELD ENTOPTOSCOPE | Koi, Inc. | 1981-12-02 |
| K800238 | MOIRE FRINGE VISOMETER AFTER LOTMAR | Hagg-Streit Service, Inc. | 1980-03-10 |
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| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06945095543923 | zumax | Zumax Medical Co., LTD | 2026-05-20 |
| 06945095544333 | zumax | Zumax Medical Co., LTD | 2026-05-20 |
| 06945095540342 | zumax | Zumax Medical Co., LTD | 2026-05-20 |
| 00812559012249 | OptochekPlus | REICHERT, INC. | 2025-08-12 |
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