Refractometer, Ophthalmic
FDA product code HKO · Class I (low risk) · 21 CFR 886.1760 · Ophthalmic
35510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Nidek, Inc. 8
- Canon USA, Inc. 4
- American Optical Corp. 3
- Stereo Optical Co., Inc. 3
- Bausch & Lomb, Inc. 2
- R.H. Burton Co. 2
- Topcon Medical Systems, Inc. 1
- Visx, Incorporated 1
- Kudi Kalu, Inc. 1
- Tomey Corporation USA 1
- Cannon U.S.A., Inc. 1
- Canon, Inc. 1
- Soderberg, Inc. 1
- Allergan Humphrey 1
- Dicon, Inc. 1
- Nippon Kogaku, Inc. 1
- Zeiss Humphrey System 1
- Coherent Medical Division 1
- Cavitron Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031831 | Topcon Model BV-1000 Automated Subjective Refraction SystemHKO · Traditional | Topcon Medical Systems, Inc. | 12/19/2003SE |
| K000327 | Wavescan Wavefront System Model HS 1HKO · Traditional | Visx, Incorporated | 05/02/2000SESU |
| K951179 | Digital Retinoscopic PhotometerHKO · Traditional | Kudi Kalu, Inc. | 05/30/1995SE |
| K945959 | Video Vision Analyzer (Viva), VRB 100HKO · Traditional | Tomey Corporation USA | 03/01/1995SE |
| K942242 | Auto Ref-Keratometer, RK-3HKO · Traditional | Cannon U.S.A., Inc. | 09/02/1994SE |
| K940516 | Auto REFF-30HKO · Traditional | Canon, Inc. | 07/12/1994SE |
| K925304 | Autoref Lensmeter RL-10HKO · Traditional | Canon USA, Inc. | 02/17/1994SE |
| K924741 | Optec 3000HKO · Traditional | Stereo Optical Co., Inc. | 04/06/1993SE |
| K924790 | Burton Auto Refractor - Model BAR-7HKO · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K924778 | Burton Auto Refractor/Keratometer - Model BARK-8HKO · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K904828 | Optec 2300 Afvt, Armed Forces Vision TesterHKO · Traditional | Stereo Optical Co., Inc. | 01/18/1991SE |
| K902500 | AR-1600G Auto-RefractometerHKO · Traditional | Nidek, Inc. | 07/27/1990SE |
| K901583 | Shin Nippon Auto Refractometer QR-007NHKO · Traditional | Soderberg, Inc. | 06/22/1990SE |
| K901513 | Nidek RT-1200S (Marco TRS-1200)HKO · Traditional | Nidek, Inc. | 06/08/1990SE |
| K890559 | Nidek AR-1200HKO · Traditional | Nidek, Inc. | 02/27/1989SE |
| K883200 | Canon Autorefractometer R-22HKO · Traditional | Canon USA, Inc. | 08/18/1988SE |
| K882287 | Canon Autorefractometer R-20HKO · Traditional | Canon USA, Inc. | 07/01/1988SE |
| K882191 | Nidek ARK-2000HKO · Traditional | Nidek, Inc. | 07/01/1988SE |
| K871611 | Allergan Humphrey Auto-Refractor, Models 525 & 540HKO · Traditional | Allergan Humphrey | 05/18/1987SE |
| K862521 | Bausch & Lomb GR-3 RefractorHKO · Traditional | Bausch & Lomb, Inc. | 07/11/1986SE |
| K861065 | AR-1100 Automatic RefractorHKO · Traditional | Nidek, Inc. | 04/09/1986SE |
| K861066 | AR-1000 Automatic RefractorHKO · Traditional | Nidek, Inc. | 04/04/1986SE |
| K861062 | AR-1600 Automatic RefractorHKO · Traditional | Nidek, Inc. | 04/04/1986SE |
| K843042 | Vision TesterHKO · Traditional | Stereo Optical Co., Inc. | 10/05/1984SE |
| K841861 | Canon Autoref R-10HKO · Traditional | Canon USA, Inc. | 10/05/1984SE |
| K831083 | Auto RefractometerHKO · Traditional | Nidek, Inc. | 06/10/1983SE |
| K820877 | Automatic Objective Refractor 2000HKO · Traditional | Dicon, Inc. | 06/25/1982SE |
| K812896 | I.V.E. Refraction SystemHKO · Traditional | Bausch & Lomb, Inc. | 12/02/1981SE |
| K812063 | SR-1V Data PrinterHKO · Traditional | American Optical Corp. | 08/18/1981SE |
| K802958 | Auto Refractometer NR-1000HKO · Traditional | Nippon Kogaku, Inc. | 04/23/1981SE |
| K802183 | Sr-Iv Programmed Subjective RefractorHKO · Traditional | American Optical Corp. | 04/23/1981SE |
| K802029 | Objective RefractorHKO · Traditional | Zeiss Humphrey System | 11/12/1980SE |
| K801906 | Dioptron III AutorefractorHKO · Traditional | Coherent Medical Division | 08/27/1980SE |
| K781014 | Autorefractor, SubjectiveHKO · Traditional | Cavitron Corp. | 09/07/1978SE |
| K771914 | Subjective Refractor, Mosel SR-111HKO · Traditional | American Optical Corp. | 11/09/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1573-2026 Class II | Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100…Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce… | Baxter Healthcare Corporation | 02/18/2026Open, Classified |
| Z-0614-2021 Class II | Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic…Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the… | Carl Zeiss Meditec AG | 08/06/2020Terminated |
| Z-1348-2018 Class II | AUTO REF/KERATOMETER ARK-1sThere is possibly a difference between the measured dioptric value of the subjective measurement mode and… | Nidek Inc. | 12/20/2017Terminated |
| Z-2477-2015 Class II | OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08…Software bug was found where there was no difference in Total and Corneal high-order aberrations, but… | Nidek Inc | 06/15/2015Terminated |
| Z-1404-2013 Class II | Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This…Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that… | Canon Inc. | 12/05/2012Terminated |