HLF · Device, Measuring, Lens Radius, Ophthalmic
Ophthalmic · 21 CFR 886.1430 · Class 1
Overview
| Product Code | HLF |
|---|---|
| Device Name | Device, Measuring, Lens Radius, Ophthalmic |
| Regulation | 21 CFR 886.1430 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic contact lens radius measuring device is an AC-powered device that is a microscope and dial gauge intended to measure the radius of a contact lens.
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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K930437 | MARCO STANDARD RADIUSGAUGES | Marco Ophthalmic, Inc. | Aug 9, 1993 | SESE |
| K862517 | BAUSCH & LOMB CONTACT LENS VIEWER | Bausch & Lomb, Inc. | Aug 11, 1986 | SESE |
| K823767 | ERG-JET ELECTRODE | Life-Tech Intl., Inc. | Jan 8, 1983 | SESE |
Top Applicants
- Bausch & Lomb, Inc. — 1 clearance
- Life-Tech Intl., Inc. — 1 clearance
- Marco Ophthalmic, Inc. — 1 clearance
