Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1750](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1750) → HMH — Rack, Skiascopic

# HMH · Rack, Skiascopic

_Ophthalmic · 21 CFR 886.1750 · Class 1_

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

## Overview

- **Product Code:** HMH
- **Device Name:** Rack, Skiascopic
- **Regulation:** [21 CFR 886.1750](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1750)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A skiascopic rack is a device that is a rack and a set of attached ophthalmic lenses of various dioptric strengths intended as an aid in refraction.

## 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 |
| --- | --- | --- | --- | --- |
| [K844364](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HMH/K844364.md) | SKIASCOPIC RACKS | Luneau Laboratories | Jan 2, 1985 | SESE |
| [K843195](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HMH/K843195.md) | VISITEC FLIERINGA-LEGRAND FIXATION RING | Visitec Co. | Oct 5, 1984 | SESE |

## Top Applicants

- Luneau Laboratories — 1 clearance
- Visitec Co. — 1 clearance

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

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