Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1570](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1570) → MSG — Ophthalmoscopes, Replacement Batteries, Hand-Held

# MSG · Ophthalmoscopes, Replacement Batteries, Hand-Held

_Ophthalmic · 21 CFR 886.1570 · Class 2_

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

## Overview

- **Product Code:** MSG
- **Device Name:** Ophthalmoscopes, Replacement Batteries, Hand-Held
- **Regulation:** [21 CFR 886.1570](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1570)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

## Classification Rationale

Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, 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 |
| --- | --- | --- | --- | --- |
| [K971108](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MSG/K971108.md) | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P | Alexander Mfg. Co. | May 6, 1997 | SESE |
| [K970268](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MSG/K970268.md) | ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY | Alexander Mfg. Co. | Mar 31, 1997 | SESE |

## Top Applicants

- Alexander Mfg. Co. — 2 clearances

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

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