FDA Product Code
FDA Product Code HKO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1760
510(k) Clearances — 35 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K031831 | TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM | Topcon Medical Systems, Inc. | 2003-12-19 | Traditional | PDF ↗ |
| K000327 | WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 | Visx, Incorporated | 2000-05-02 | Traditional | PDF ↗ |
| K951179 | DIGITAL RETINOSCOPIC PHOTOMETER | Kudi Kalu, Inc. | 1995-05-30 | Traditional | PDF ↗ |
| K945959 | VIDEO VISION ANALYZER (VIVA), VRB 100 | Tomey Corporation USA | 1995-03-01 | Traditional | PDF ↗ |
| K942242 | AUTO REF-KERATOMETER, RK-3 | Cannon U.S.A., Inc. | 1994-09-02 | Traditional | PDF ↗ |
| K940516 | AUTO REFF-30 | Canon, Inc. | 1994-07-12 | Traditional | PDF ↗ |
| K925304 | AUTOREF LENSMETER RL-10 | Canon USA, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K924741 | OPTEC 3000 | Stereo Optical Co., Inc. | 1993-04-06 | Traditional | PDF ↗ |
| K924778 | BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 | R.H. Burton Co. | 1993-04-05 | Traditional | PDF ↗ |
| K924790 | BURTON AUTO REFRACTOR - MODEL BAR-7 | R.H. Burton Co. | 1993-04-05 | Traditional | PDF ↗ |
| K904828 | OPTEC 2300 AFVT, ARMED FORCES VISION TESTER | Stereo Optical Co., Inc. | 1991-01-18 | Traditional | PDF ↗ |
| K902500 | AR-1600G AUTO-REFRACTOMETER | Nidek, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901583 | SHIN NIPPON AUTO REFRACTOMETER QR-007N | Soderberg, Inc. | 1990-06-22 | Traditional | PDF ↗ |
| K901513 | NIDEK RT-1200S (MARCO TRS-1200) | Nidek, Inc. | 1990-06-08 | Traditional | PDF ↗ |
| K890559 | NIDEK AR-1200 | Nidek, Inc. | 1989-02-27 | Traditional | PDF ↗ |
| K883200 | CANON AUTOREFRACTOMETER R-22 | Canon USA, Inc. | 1988-08-18 | Traditional | PDF ↗ |
| K882287 | CANON AUTOREFRACTOMETER R-20 | Canon USA, Inc. | 1988-07-01 | Traditional | PDF ↗ |
| K882191 | NIDEK ARK-2000 | Nidek, Inc. | 1988-07-01 | Traditional | PDF ↗ |
| K871611 | ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540 | Allergan Humphrey | 1987-05-18 | Traditional | PDF ↗ |
| K862521 | BAUSCH & LOMB GR-3 REFRACTOR | Bausch & Lomb, Inc. | 1986-07-11 | Traditional | PDF ↗ |
| K861065 | AR-1100 AUTOMATIC REFRACTOR | Nidek, Inc. | 1986-04-09 | Traditional | PDF ↗ |
| K861066 | AR-1000 AUTOMATIC REFRACTOR | Nidek, Inc. | 1986-04-04 | Traditional | PDF ↗ |
| K861062 | AR-1600 AUTOMATIC REFRACTOR | Nidek, Inc. | 1986-04-04 | Traditional | PDF ↗ |
| K841861 | CANON AUTOREF R-10 | Canon USA, Inc. | 1984-10-05 | Traditional | PDF ↗ |
| K843042 | VISION TESTER | Stereo Optical Co., Inc. | 1984-10-05 | Traditional | PDF ↗ |
| K831083 | AUTO REFRACTOMETER | Nidek, Inc. | 1983-06-10 | Traditional | PDF ↗ |
| K820877 | AUTOMATIC OBJECTIVE REFRACTOR 2000 | Dicon, Inc. | 1982-06-25 | Traditional | PDF ↗ |
| K812896 | I.V.E. REFRACTION SYSTEM | Bausch & Lomb, Inc. | 1981-12-02 | Traditional | PDF ↗ |
| K812063 | SR-1V DATA PRINTER | American Optical Corp. | 1981-08-18 | Traditional | PDF ↗ |
| K802958 | AUTO REFRACTOMETER NR-1000 | Nippon Kogaku, Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K802183 | SR-IV PROGRAMMED SUBJECTIVE REFRACTOR | American Optical Corp. | 1981-04-23 | Traditional | PDF ↗ |
| K802029 | OBJECTIVE REFRACTOR | Zeiss Humphrey System | 1980-11-12 | Traditional | PDF ↗ |
| K801906 | DIOPTRON III AUTOREFRACTOR | Coherent Medical Division | 1980-08-27 | Traditional | PDF ↗ |
| K781014 | AUTOREFRACTOR, SUBJECTIVE | Cavitron Corp. | 1978-09-07 | Traditional | PDF ↗ |
| K771914 | SUBJECTIVE REFRACTOR, MOSEL SR-111 | American Optical Corp. | 1977-11-09 | Traditional | PDF ↗ |
Product code HKO · Class I · Ophthalmic. Data: openFDA.