HKO · Refractometer, Ophthalmic
Ophthalmic · 21 CFR 886.1760 · Class 1
Overview
| Product Code | HKO |
|---|---|
| Device Name | Refractometer, Ophthalmic |
| Regulation | 21 CFR 886.1760 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Recent Cleared Devices (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K031831 | TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM | Topcon Medical Systems, Inc. | Dec 19, 2003 | SESE |
| K000327 | WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 | Visx, Incorporated | May 2, 2000 | SESU |
| K951179 | DIGITAL RETINOSCOPIC PHOTOMETER | Kudi Kalu, Inc. | May 30, 1995 | SESE |
| K945959 | VIDEO VISION ANALYZER (VIVA), VRB 100 | Tomey Corporation USA | Mar 1, 1995 | SESE |
| K942242 | AUTO REF-KERATOMETER, RK-3 | Cannon U.S.A., Inc. | Sep 2, 1994 | SESE |
| K940516 | AUTO REFF-30 | Canon, Inc. | Jul 12, 1994 | SESE |
| K925304 | AUTOREF LENSMETER RL-10 | Canon USA, Inc. | Feb 17, 1994 | SESE |
| K924741 | OPTEC 3000 | Stereo Optical Co., Inc. | Apr 6, 1993 | SESE |
| K924790 | BURTON AUTO REFRACTOR - MODEL BAR-7 | R.H. Burton Co. | Apr 5, 1993 | SESE |
| K924778 | BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 | R.H. Burton Co. | Apr 5, 1993 | SESE |
| K904828 | OPTEC 2300 AFVT, ARMED FORCES VISION TESTER | Stereo Optical Co., Inc. | Jan 18, 1991 | SESE |
| K902500 | AR-1600G AUTO-REFRACTOMETER | Nidek, Inc. | Jul 27, 1990 | SESE |
| K901583 | SHIN NIPPON AUTO REFRACTOMETER QR-007N | Soderberg, Inc. | Jun 22, 1990 | SESE |
| K901513 | NIDEK RT-1200S (MARCO TRS-1200) | Nidek, Inc. | Jun 8, 1990 | SESE |
| K890559 | NIDEK AR-1200 | Nidek, Inc. | Feb 27, 1989 | SESE |
| K883200 | CANON AUTOREFRACTOMETER R-22 | Canon USA, Inc. | Aug 18, 1988 | SESE |
| K882287 | CANON AUTOREFRACTOMETER R-20 | Canon USA, Inc. | Jul 1, 1988 | SESE |
| K882191 | NIDEK ARK-2000 | Nidek, Inc. | Jul 1, 1988 | SESE |
| K871611 | ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540 | Allergan Humphrey | May 18, 1987 | SESE |
| K862521 | BAUSCH & LOMB GR-3 REFRACTOR | Bausch & Lomb, Inc. | Jul 11, 1986 | SESE |
Top Applicants
- Nidek, Inc. — 8 clearances
- Canon USA, Inc. — 4 clearances
- American Optical Corp. — 3 clearances
- Stereo Optical Co., Inc. — 3 clearances
- Bausch & Lomb, Inc. — 2 clearances
