Instrument, Measuring, Corneal Radius
The Corneal Radius Measuring Instrument is an ophthalmic device used to quantify the curvature of the cornea, providing measurements essential for contact lens fitting, keratoconus monitoring, and pre-surgical corneal assessment. It is classified as FDA Class 1, meaning it presents the lowest level of risk and requires only general controls such as proper labeling and establishment registration. The product code is HJB, regulated under 21 CFR 886.1450, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HJB
- Device Class
- FDA class 1
- Regulation Number
- 886.1450
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K930444 | MARCO STANDARD KERATOMETERS | Aug 09, 1993 | Substantially Equivalent | Marco Ophthalmic, Inc. |
| K924779 | BURTON KERATOMETER - MODLE 2040 | Apr 05, 1993 | Substantially Equivalent | R.H. Burton Co. |
| K864369 | LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER | Dec 15, 1986 | Substantially Equivalent | Heidelberg Instruments |
| K864037 | KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER | Nov 13, 1986 | Substantially Equivalent | Kera Corp. |
| K852424 | ACUFEX COMPARATIVE SURGICAL KERATOMETER | Sep 11, 1985 | Substantially Equivalent | Acufex Microsurgical, Inc. |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.