Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1930](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1930) → HLA — Calibrator, Tonometer

# HLA · Calibrator, Tonometer

_Ophthalmic · 21 CFR 886.1930 · Class 2_

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

## Overview

- **Product Code:** HLA
- **Device Name:** Calibrator, Tonometer
- **Regulation:** [21 CFR 886.1930](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1930)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

## Classification Rationale

Class II.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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