Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart E — Surgical Devices](/submissions/EN/subpart-e%E2%80%94surgical-devices) → [21 CFR 874.4750](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4750) → EQL — Laryngostroboscope

# EQL · Laryngostroboscope

_Ear, Nose, Throat · 21 CFR 874.4750 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQL

## Overview

- **Product Code:** EQL
- **Device Name:** Laryngostroboscope
- **Regulation:** [21 CFR 874.4750](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4750)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. The light and microphone that amplifies acoustic signals from the glottic area may or may not contact the patient.

## 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 § 874.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K984521](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQL/K984521.md) | RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 | Richard Wolf Medical Instruments Corp. | Mar 17, 1999 | SESE |
| [K921285](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQL/K921285.md) | 9105 RIGID TELESCOPIC ENDOSCOPE | Kay Elemetrics Corp. | May 28, 1992 | SESE |
| [K921184](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQL/K921184.md) | RLS 9100 RHINO-LARYNGEAL STROBOSCOPE | Kay Elemetrics Corp. | May 28, 1992 | SESE |
| [K884933](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQL/K884933.md) | ENDOSTROBOSCOPE IV | Jedmed Instrument Co. | Feb 15, 1989 | SESE |
| [K842090](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQL/K842090.md) | RHINO-LARYNX STROBOSCOPE TYPE 4914 | Bruel & Kjaer Industri A/S | Jul 18, 1984 | SESE |
| [K822523](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQL/K822523.md) | LARYNGOSTROBOSCOPE | Kelleher Corp. | Sep 9, 1982 | SESE |
| [K801866](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQL/K801866.md) | PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A | Pentax Precision Instrument Corp. | Sep 16, 1980 | SESE |
| [K770466](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQL/K770466.md) | STOCKINGS, RVS TM | Parke-Davis Co. | Mar 28, 1977 | SESE |

## Top Applicants

- Kay Elemetrics Corp. — 2 clearances
- Bruel & Kjaer Industri A/S — 1 clearance
- Jedmed Instrument Co. — 1 clearance
- Kelleher Corp. — 1 clearance
- Parke-Davis Co. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQL](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQL)

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