Device, Measuring, Lens Radius, Ophthalmic
The Ophthalmic Lens Radius Measuring Device is an instrument used to determine the curvature radius of ophthalmic lenses, ensuring that prescribed spectacle or contact lenses conform to the intended optical parameters. It is classified as FDA Class 1, representing the lowest risk level, requiring only general controls without any premarket submission. The product code is HLF, regulated under 21 CFR 886.1430, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HLF
- Device Class
- FDA class 1
- Regulation Number
- 886.1430
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K930437 | MARCO STANDARD RADIUSGAUGES | Aug 09, 1993 | Substantially Equivalent | Marco Ophthalmic, Inc. |
| K862517 | BAUSCH & LOMB CONTACT LENS VIEWER | Aug 11, 1986 | Substantially Equivalent | Bausch & Lomb, Inc. |
| K823767 | ERG-JET ELECTRODE | Jan 08, 1983 | Substantially Equivalent | Life-Tech Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.