Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1430](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1430) → HLF — Device, Measuring, Lens Radius, Ophthalmic

# HLF · Device, Measuring, Lens Radius, Ophthalmic

_Ophthalmic · 21 CFR 886.1430 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLF

## Overview

- **Product Code:** HLF
- **Device Name:** Device, Measuring, Lens Radius, Ophthalmic
- **Regulation:** [21 CFR 886.1430](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1430)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLF/K930437.md) | MARCO STANDARD RADIUSGAUGES | Marco Ophthalmic, Inc. | Aug 9, 1993 | SESE |
| [K862517](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLF/K862517.md) | BAUSCH & LOMB CONTACT LENS VIEWER | Bausch & Lomb, Inc. | Aug 11, 1986 | SESE |
| [K823767](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLF/K823767.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLF](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLF)

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