Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4100](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4100) → HQR — Apparatus, Cautery, Radiofrequency, Ac-Powered

# HQR · Apparatus, Cautery, Radiofrequency, Ac-Powered

_Ophthalmic · 21 CFR 886.4100 · Class 2_

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

## Overview

- **Product Code:** HQR
- **Device Name:** Apparatus, Cautery, Radiofrequency, Ac-Powered
- **Regulation:** [21 CFR 886.4100](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4100)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

## Classification Rationale

Class II.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K050308](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K050308.md) | THERMAL CAUTERY PROBE | Starion Instruments | Feb 25, 2005 | SESE |
| [K990064](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K990064.md) | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM | Ophthalmic Technologies, Inc. | Apr 4, 1999 | SESE |
| [K980522](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K980522.md) | REFRACTEC MCS-100 | Refractec, Inc. | Jul 22, 1998 | SESU |
| [K972749](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K972749.md) | PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) | C.M. Chance , Ltd. | Mar 13, 1998 | SESE |
| [K952151](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K952151.md) | STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) | Storz | Mar 4, 1996 | SESE |
| [K955158](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K955158.md) | SURGITRON | Ellman Intl., Inc. | Feb 9, 1996 | SESE |
| [K952569](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K952569.md) | GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR | Gamp & Assoc. | Jan 5, 1996 | SESE |
| [K941495](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K941495.md) | RETURN PATH DIATHERMY HANDLE | Mira, Inc. | Jul 15, 1994 | SESE |
| [K934320](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K934320.md) | MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION | Mentor O & O, Inc. | Feb 16, 1994 | SESE |
| [K895800](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K895800.md) | ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR | Advanced Surgical Products, Inc. | Jan 22, 1990 | SESE |
| [K870194](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K870194.md) | UNITED SURGICAL CORP. DIATHERMIC PLUS | United Surgical Corp. | Feb 20, 1987 | SESE |

## Top Applicants

- United Surgical Corp. — 1 clearance
- Storz — 1 clearance
- Starion Instruments — 1 clearance
- Refractec, Inc. — 1 clearance
- Ophthalmic Technologies, Inc. — 1 clearance

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

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