Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4700](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4700) → HRM — Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

# HRM · Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

_General, Plastic Surgery · 21 CFR 878.4700 · Class 1_

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

## Overview

- **Product Code:** HRM
- **Device Name:** Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
- **Regulation:** [21 CFR 878.4700](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4700)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

## 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 § 878.9.

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K932720](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K932720.md) | HM-0970 | Hill-Med, Inc. | Sep 7, 1993 | SESE |
| [K930439](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K930439.md) | MARCO SURGISCOPE OPERATION MICROSCOPES | Marco Ophthalmic, Inc. | Jul 22, 1993 | SESE |
| [K920641](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K920641.md) | ALCON OPERATING MICROSCOPES | Alcon Laboratories | Oct 9, 1992 | SESE |
| [K914956](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K914956.md) | KEELER KONAN SPECULAR MICROSCOPE SP5500 | Keeler Instruments, Inc. | Feb 3, 1992 | SESE |
| [K891584](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K891584.md) | S 22 INSTRUMENT STAND | Carl Zeiss, Inc. | Jun 8, 1989 | SESE |
| [K891001](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K891001.md) | MICROSCOPE KNOB COVER, STERILE, DISPOSABLE | Prescott'S, Inc. | Apr 11, 1989 | SESE |
| [K854440](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K854440.md) | MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 | Keeler Instruments, Inc. | Dec 16, 1985 | SESE |
| [K853855](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K853855.md) | XTAL X-150 OPERATING MICROSCOPE | Xtal Corp. | Oct 15, 1985 | SESE |
| [K852586](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K852586.md) | CROMIC SURGICAL MICROSCOPE MODEL MC-1 | Seltrex, Corp. | Jul 30, 1985 | SESE |
| [K852150](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K852150.md) | CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 | Keeler Instruments, Inc. | Jun 3, 1985 | SESE |
| [K850270](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K850270.md) | CORNEAL LIGHT SHIELD | Mentor O & O, Inc. | May 31, 1985 | SESE |
| [K844323](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K844323.md) | KONAN CLINIC MICROSCOPE CLM-100-150 | Keeler Instruments, Inc. | Nov 21, 1984 | SESE |
| [K822563](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K822563.md) | OPHTHALMIC MICROSCOPE | Treace Medical, Inc. | Sep 14, 1982 | SESE |
| [K792083](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HRM/K792083.md) | HAAG-STREIT SLIT LAMP 900 | Lumenis, Inc. | Nov 16, 1979 | SESE |

## Top Applicants

- Keeler Instruments, Inc. — 4 clearances
- Alcon Laboratories — 1 clearance
- Carl Zeiss, Inc. — 1 clearance
- Hill-Med, Inc. — 1 clearance
- Lumenis, Inc. — 1 clearance

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

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