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) → HJM — Transilluminator, Ac-Powered

# HJM · Transilluminator, Ac-Powered

_Ophthalmic · 21 CFR 886.1945 · Class 2_

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

## Overview

- **Product Code:** HJM
- **Device Name:** Transilluminator, Ac-Powered
- **Regulation:** [21 CFR 886.1945](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1945)
- **Device Class:** 2
- **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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K972506](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K972506.md) | INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR | Infinitech, Inc. | Oct 1, 1997 | SESE |
| [K950529](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K950529.md) | PEREGRINE DIFFUSION LIGHT PIPE | Peregrine Surgical , Ltd. | Jun 7, 1995 | SESE |
| [K945877](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K945877.md) | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | Wells Johnson Co. | Mar 2, 1995 | SESE |
| [K931072](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K931072.md) | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | Hgm, Inc. | Nov 10, 1994 | SESE |
| [K933445](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K933445.md) | DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) | Storz Instrument Co. | Sep 23, 1994 | SESE |
| [K940393](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K940393.md) | PEREGRINE WIDE ANGLE LIGHT PIPE | Peregrine Surgical , Ltd. | Sep 2, 1994 | SESE |
| [K934269](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K934269.md) | FIBEROPTIC ILLUMINATED INSTRUMENTS | Visitec Co. | May 17, 1994 | SESE |
| [K913273](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K913273.md) | DROLITE(TM) LIGHT SOURCE | Vision Medical, Inc. | Dec 4, 1991 | SESE |
| [K894513](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K894513.md) | DIATHRON(R) DIATHERMY UNIT | Intl. Ophthalmic Industries Corp. | Oct 31, 1989 | SESE |
| [K893170](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K893170.md) | VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) | Keeler Instruments, Inc. | Jun 5, 1989 | SESE |
| [K812949](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K812949.md) | RMI TRANSILLUMINATOR, MODEL 292 | Radiation Measurements, Inc. | Dec 2, 1981 | SESE |
| [K811108](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K811108.md) | RMI TRANSILLUMINATION LIGHT METER #295 | Radiation Measurements, Inc. | Jul 1, 1981 | SESE |

## Top Applicants

- Peregrine Surgical , Ltd. — 2 clearances
- Radiation Measurements, Inc. — 2 clearances
- Hgm, Inc. — 1 clearance
- Infinitech, Inc. — 1 clearance
- Intl. Ophthalmic Industries Corp. — 1 clearance

---

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

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