HJB · Instrument, Measuring, Corneal Radius
Ophthalmic · 21 CFR 886.1450 · Class 1
Overview
| Product Code | HJB |
|---|---|
| Device Name | Instrument, Measuring, Corneal Radius |
| Regulation | 21 CFR 886.1450 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier.
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, only when the device does not include computer software in the unit or topographers.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K930444 | MARCO STANDARD KERATOMETERS | Marco Ophthalmic, Inc. | Aug 9, 1993 | SESE |
| K924779 | BURTON KERATOMETER - MODLE 2040 | R.H. Burton Co. | Apr 5, 1993 | SESE |
| K864369 | LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER | Heidelberg Instruments | Dec 15, 1986 | SESE |
| K864037 | KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER | Kera Corp. | Nov 13, 1986 | SESE |
| K852424 | ACUFEX COMPARATIVE SURGICAL KERATOMETER | Acufex Microsurgical, Inc. | Sep 11, 1985 | SESE |
Top Applicants
- R.H. Burton Co. — 1 clearance
- Marco Ophthalmic, Inc. — 1 clearance
- Kera Corp. — 1 clearance
- Heidelberg Instruments — 1 clearance
- Acufex Microsurgical, Inc. — 1 clearance
