HLQ · Keratoscope, Ac-Powered
Ophthalmic · 21 CFR 886.1350 · Class 1
Overview
| Product Code | HLQ |
|---|---|
| Device Name | Keratoscope, Ac-Powered |
| Regulation | 21 CFR 886.1350 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.
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 § 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K003299 | OPD-SCAN, MODELS ARK-10000 AND ARK-9000 | Nidek Co., Ltd. | Mar 9, 2001 | SESU |
| K973756 | EYE SYS VISTA | Eyesys Technologies, Inc. | Nov 13, 1997 | SESE |
| K964290 | EYECHEK | Reichert Ophthalmic Instruments, Div. Leica, Inc. | Jan 9, 1997 | SESE |
| K945382 | TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER | Expertech Assoc., Inc. | Jan 31, 1995 | SESE |
| K944207 | TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 | Computed Anatomy, Inc. | Dec 7, 1994 | SESE |
| K944616 | KERATRON CORNEAL TOPOGRAPHER | Alliance Medical Marketinig | Nov 22, 1994 | SESE |
| K940647 | ORBSCAN(TM) KERATOMETER | Orbtek, Inc. | Jul 6, 1994 | SESE |
| K933556 | EH-270 CORNEAL TOPOGRAPHER | Visioptic, Inc. | Nov 2, 1993 | SESE |
| K923435 | CORNEAL TOPOGRAPHY SYSTEM | Par Microsystems Corp. | Feb 16, 1993 | SESE |
| K922253 | KERATOREF L60 | Luneau Ophtalmologie SA | Jun 19, 1992 | SESE |
| K912740 | ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) | Visionary Systems, Inc. | Dec 30, 1991 | SESE |
| K913022 | CCI VIDEOKERATOSCOPE/COMPARATOR | Cci | Oct 9, 1991 | SESE |
| K912130 | TBD KERATOSCOPE | Alcon Laboratories | Aug 9, 1991 | SESE |
| K895741 | CLAS PHOTOKERATOSCOPE | Kera-Metrics Corp. | Jul 11, 1990 | SESE |
| K902012 | VKS-1 VIDEO KERATOSCOPE | Computed Anatomy, Inc. | Jun 22, 1990 | SESE |
| K901009 | MODEL 2000 INTRAOPERATIVE CORNEASCOPE | Kera Corp. | May 30, 1990 | SESE |
| K901363 | TOPOGRAPHIC MODELING SYSTEM | Computed Anatomy, Inc. | May 25, 1990 | SESE |
| K895475 | CANON AUTO REF-KERATOMETER RK-2 | Canon USA, Inc. | Oct 31, 1989 | SESE |
| K890687 | ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER | Optimed, Inc. | Sep 5, 1989 | SESE |
| K871936 | CANON SURGICAL AUTO KERATOMETER SK-1 | Canon USA, Inc. | Jun 19, 1987 | SESE |
Top Applicants
- Computed Anatomy, Inc. — 3 clearances
- Kera Corp. — 3 clearances
- Nidek, Inc. — 3 clearances
- Canon USA, Inc. — 2 clearances
- Alcon Laboratories — 1 clearance
