Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1660](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1660) → HKS — Prism, Gonioscopic

# HKS · Prism, Gonioscopic

_Ophthalmic · 21 CFR 886.1660 · Class 1_

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

## Overview

- **Product Code:** HKS
- **Device Name:** Prism, Gonioscopic
- **Regulation:** [21 CFR 886.1660](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1660)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.

## 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 (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K140368](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKS/K140368.md) | FAMILY OF DISPOSABLE LENSES | Sensor Medical Technology, LLC | Apr 29, 2014 | SESE |
| [K935302](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKS/K935302.md) | OSHER SURGICAL GONIO/POSTERIOR  POLE LENS | Ocular Instruments, Inc. | Apr 1, 1994 | SESE |
| [K895846](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKS/K895846.md) | TWO MIRROR GONIO LENS | Ocular Instruments, Inc. | Dec 18, 1989 | SESE |
| [K890977](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKS/K890977.md) | MCINTYRE SURGICAL GONIOLENS | Ocular Instruments, Inc. | May 23, 1989 | SESE |
| [K862713](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKS/K862713.md) | ABRAHAM IRIDECTOMY LENS (YAG LASER) | Ocular Instruments, Inc. | Aug 21, 1986 | SESE |
| [K862692](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKS/K862692.md) | KARICKHOFF DIAGNOSTIC/LASER LENS | Ocular Instruments, Inc. | Aug 21, 1986 | SESE |
| [K862512](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKS/K862512.md) | RITCH TRABECULOPLASTY LASER LENS | Ocular Instruments, Inc. | Jul 11, 1986 | SESE |
| [K862024](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKS/K862024.md) | SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM | Ocular Instruments, Inc. | Jul 11, 1986 | SESE |
| [K861027](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKS/K861027.md) | KETA HAND-HELD TONOMETER | Keta Corp. | May 6, 1986 | SESE |
| [K830169](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKS/K830169.md) | DORC ADJUSTABLE IMAGE CONTACTS | Jedmed Instrument Co. | Feb 7, 1983 | SESE |

## Top Applicants

- Ocular Instruments, Inc. — 7 clearances
- Jedmed Instrument Co. — 1 clearance
- Keta Corp. — 1 clearance
- Sensor Medical Technology, LLC — 1 clearance

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

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