Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1945](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1945) → HJN — Transilluminator, Battery-Powered

# HJN · Transilluminator, Battery-Powered

_Ophthalmic · 21 CFR 886.1945 · Class 1_

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

## Overview

- **Product Code:** HJN
- **Device Name:** Transilluminator, Battery-Powered
- **Regulation:** [21 CFR 886.1945](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1945)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.

## Classification Rationale

(1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device 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.* (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K941035](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJN/K941035.md) | VENOSCOPE | Trinity Partners, LLC | May 16, 1994 | SESE |
| [K912747](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJN/K912747.md) | LULMITEX NEONATAL TRANSILLUMINATOR | Lumitex, Inc. | Dec 24, 1991 | SESE |
| [K901309](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJN/K901309.md) | SYLVAN PEDIASCAN 200 TRANSILLUMINATOR | Sylvan Corp. | May 24, 1990 | SESE |

## Top Applicants

- Lumitex, Inc. — 1 clearance
- Sylvan Corp. — 1 clearance
- Trinity Partners, LLC — 1 clearance

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

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