Panels › Ophthalmic › Product code HKO · Class 1
Refractometer, Ophthalmic
Regulation 886.1760
0510(k)s in 12 months (35 all time)
1recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in HKO
| Company | 510(k)s | Recalls |
|---|---|---|
| Nidek, Inc. | 8 | 2 |
| Canon USA, Inc. | 5 | 1 |
| American Optical Corp. | 3 | 0 |
| Stereo Optical Co., Inc. | 3 | 0 |
| Bausch & Lomb, Inc. | 2 | 0 |
| R.H. Burton Co. | 2 | 0 |
| Allergan Humphrey | 1 | 0 |
| Baxter Healthcare Corporation | 0 | 1 |
| Cannon U.S.A., Inc. | 1 | 0 |
| Carl Zeiss Meditec AG | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2003 | K031831 | TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM Topcon Medical Systems, Inc. | HKO |
| May 2, 2000 | K000327 | WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 Visx, Incorporated | HKO |
| May 30, 1995 | K951179 | DIGITAL RETINOSCOPIC PHOTOMETER Kudi Kalu, Inc. | HKO |
| Mar 1, 1995 | K945959 | VIDEO VISION ANALYZER (VIVA), VRB 100 Tomey Corporation USA | HKO |
| Sep 2, 1994 | K942242 | AUTO REF-KERATOMETER, RK-3 Cannon U.S.A., Inc. | HKO |
| Jul 12, 1994 | K940516 | AUTO REFF-30 Canon, Inc., JP | HKO |
| Feb 17, 1994 | K925304 | AUTOREF LENSMETER RL-10 Canon USA, Inc., JP | HKO |
| Apr 6, 1993 | K924741 | OPTEC 3000 Stereo Optical Co., Inc. | HKO |
| Apr 5, 1993 | K924790 | BURTON AUTO REFRACTOR - MODEL BAR-7 R.H. Burton Co. | HKO |
| Apr 5, 1993 | K924778 | BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 R.H. Burton Co. | HKO |
| Jan 18, 1991 | K904828 | OPTEC 2300 AFVT, ARMED FORCES VISION TESTER Stereo Optical Co., Inc. | HKO |
| Jul 27, 1990 | K902500 | AR-1600G AUTO-REFRACTOMETER Nidek, Inc. | HKO |
| Jun 22, 1990 | K901583 | SHIN NIPPON AUTO REFRACTOMETER QR-007N Soderberg, Inc. | HKO |
| Jun 8, 1990 | K901513 | NIDEK RT-1200S (MARCO TRS-1200) Nidek, Inc. | HKO |
| Feb 27, 1989 | K890559 | NIDEK AR-1200 Nidek, Inc. | HKO |
| Aug 18, 1988 | K883200 | CANON AUTOREFRACTOMETER R-22 Canon USA, Inc. | HKO |
| Jul 1, 1988 | K882287 | CANON AUTOREFRACTOMETER R-20 Canon USA, Inc. | HKO |
| Jul 1, 1988 | K882191 | NIDEK ARK-2000 Nidek, Inc. | HKO |
| May 18, 1987 | K871611 | ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540 Allergan Humphrey | HKO |
| Jul 11, 1986 | K862521 | BAUSCH & LOMB GR-3 REFRACTOR Bausch & Lomb, Inc. | HKO |
| Apr 9, 1986 | K861065 | AR-1100 AUTOMATIC REFRACTOR Nidek, Inc. | HKO |
| Apr 4, 1986 | K861066 | AR-1000 AUTOMATIC REFRACTOR Nidek, Inc. | HKO |
| Apr 4, 1986 | K861062 | AR-1600 AUTOMATIC REFRACTOR Nidek, Inc. | HKO |
| Oct 5, 1984 | K843042 | VISION TESTER Stereo Optical Co., Inc. | HKO |
| Oct 5, 1984 | K841861 | CANON AUTOREF R-10 Canon USA, Inc. | HKO |
| Jun 10, 1983 | K831083 | AUTO REFRACTOMETER Nidek, Inc. | HKO |
| Jun 25, 1982 | K820877 | AUTOMATIC OBJECTIVE REFRACTOR 2000 Dicon, Inc. | HKO |
| Dec 2, 1981 | K812896 | I.V.E. REFRACTION SYSTEM Bausch & Lomb, Inc. | HKO |
| Aug 18, 1981 | K812063 | SR-1V DATA PRINTER American Optical Corp. | HKO |
| Apr 23, 1981 | K802958 | AUTO REFRACTOMETER NR-1000 Nippon Kogaku, Inc. | HKO |
| Apr 23, 1981 | K802183 | SR-IV PROGRAMMED SUBJECTIVE REFRACTOR American Optical Corp. | HKO |
| Nov 12, 1980 | K802029 | OBJECTIVE REFRACTOR Zeiss Humphrey System | HKO |
| Aug 27, 1980 | K801906 | DIOPTRON III AUTOREFRACTOR Coherent Medical Division | HKO |
| Sep 7, 1978 | K781014 | AUTOREFRACTOR, SUBJECTIVE Cavitron Corp. | HKO |
| Nov 9, 1977 | K771914 | SUBJECTIVE REFRACTOR, MOSEL SR-111 American Optical Corp. | HKO |
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