HJM · Transilluminator, Ac-Powered
Ophthalmic · 21 CFR 886.1945 · Class 2
Overview
| Product Code | HJM |
|---|---|
| Device Name | Transilluminator, Ac-Powered |
| Regulation | 21 CFR 886.1945 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
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 | INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR | Infinitech, Inc. | Oct 1, 1997 | SESE |
| K950529 | PEREGRINE DIFFUSION LIGHT PIPE | Peregrine Surgical , Ltd. | Jun 7, 1995 | SESE |
| K945877 | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | Wells Johnson Co. | Mar 2, 1995 | SESE |
| K931072 | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | Hgm, Inc. | Nov 10, 1994 | SESE |
| K933445 | DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) | Storz Instrument Co. | Sep 23, 1994 | SESE |
| K940393 | PEREGRINE WIDE ANGLE LIGHT PIPE | Peregrine Surgical , Ltd. | Sep 2, 1994 | SESE |
| K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS | Visitec Co. | May 17, 1994 | SESE |
| K913273 | DROLITE(TM) LIGHT SOURCE | Vision Medical, Inc. | Dec 4, 1991 | SESE |
| K894513 | DIATHRON(R) DIATHERMY UNIT | Intl. Ophthalmic Industries Corp. | Oct 31, 1989 | SESE |
| K893170 | VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) | Keeler Instruments, Inc. | Jun 5, 1989 | SESE |
| K812949 | RMI TRANSILLUMINATOR, MODEL 292 | Radiation Measurements, Inc. | Dec 2, 1981 | SESE |
| K811108 | RMI TRANSILLUMINATION LIGHT METER #295 | Radiation Measurements, Inc. | Jul 1, 1981 | SESE |
Top Applicants
- Radiation Measurements, Inc. — 2 clearances
- Peregrine Surgical , Ltd. — 2 clearances
- Wells Johnson Co. — 1 clearance
- Visitec Co. — 1 clearance
- Vision Medical, Inc. — 1 clearance
