Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1420](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1420) → HLN — Gauge, Lens, Ophthalmic

# HLN · Gauge, Lens, Ophthalmic

_Ophthalmic · 21 CFR 886.1420 · Class 1_

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

## Overview

- **Product Code:** HLN
- **Device Name:** Gauge, Lens, Ophthalmic
- **Regulation:** [21 CFR 886.1420](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1420)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K852054](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLN/K852054.md) | CONTACT LENS LOUPE, INSPETION LOUPE | Ascon Medical Instruments, Ltd. | Sep 5, 1985 | SESE |
| [K801466](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLN/K801466.md) | LEIGH MEASURING SCALE #7725 | Edward Weck, Inc. | Jul 28, 1980 | SESE |

## Top Applicants

- Ascon Medical Instruments, Ltd. — 1 clearance
- Edward Weck, Inc. — 1 clearance

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

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