Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1760](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1760) → HKO — Refractometer, Ophthalmic # HKO · Refractometer, Ophthalmic _Ophthalmic · 21 CFR 886.1760 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO ## Overview - **Product Code:** HKO - **Device Name:** Refractometer, Ophthalmic - **Regulation:** [21 CFR 886.1760](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1760) - **Device Class:** 1 - **Review Panel:** [Ophthalmic](/submissions/OP) ## 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](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K031831.md) | TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM | Topcon Medical Systems, Inc. | Dec 19, 2003 | SESE | | [K000327](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K000327.md) | WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 | Visx, Incorporated | May 2, 2000 | SESU | | [K951179](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K951179.md) | DIGITAL RETINOSCOPIC PHOTOMETER | Kudi Kalu, Inc. | May 30, 1995 | SESE | | [K945959](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K945959.md) | VIDEO VISION ANALYZER (VIVA), VRB 100 | Tomey Corporation USA | Mar 1, 1995 | SESE | | [K942242](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K942242.md) | AUTO REF-KERATOMETER, RK-3 | Cannon U.S.A., Inc. | Sep 2, 1994 | SESE | | [K940516](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K940516.md) | AUTO REFF-30 | Canon, Inc. | Jul 12, 1994 | SESE | | [K925304](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K925304.md) | AUTOREF LENSMETER RL-10 | Canon USA, Inc. | Feb 17, 1994 | SESE | | [K924741](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K924741.md) | OPTEC 3000 | Stereo Optical Co., Inc. | Apr 6, 1993 | SESE | | [K924790](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K924790.md) | BURTON AUTO REFRACTOR - MODEL BAR-7 | R.H. Burton Co. | Apr 5, 1993 | SESE | | [K924778](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K924778.md) | BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 | R.H. Burton Co. | Apr 5, 1993 | SESE | | [K904828](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K904828.md) | OPTEC 2300 AFVT, ARMED FORCES VISION TESTER | Stereo Optical Co., Inc. | Jan 18, 1991 | SESE | | [K902500](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K902500.md) | AR-1600G AUTO-REFRACTOMETER | Nidek, Inc. | Jul 27, 1990 | SESE | | [K901583](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K901583.md) | SHIN NIPPON AUTO REFRACTOMETER QR-007N | Soderberg, Inc. | Jun 22, 1990 | SESE | | [K901513](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K901513.md) | NIDEK RT-1200S (MARCO TRS-1200) | Nidek, Inc. | Jun 8, 1990 | SESE | | [K890559](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K890559.md) | NIDEK AR-1200 | Nidek, Inc. | Feb 27, 1989 | SESE | | [K883200](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K883200.md) | CANON AUTOREFRACTOMETER R-22 | Canon USA, Inc. | Aug 18, 1988 | SESE | | [K882287](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K882287.md) | CANON AUTOREFRACTOMETER R-20 | Canon USA, Inc. | Jul 1, 1988 | SESE | | [K882191](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K882191.md) | NIDEK ARK-2000 | Nidek, Inc. | Jul 1, 1988 | SESE | | [K871611](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K871611.md) | ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540 | Allergan Humphrey | May 18, 1987 | SESE | | [K862521](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K862521.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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