HJN · Transilluminator, Battery-Powered
Ophthalmic · 21 CFR 886.1945 · Class 1
Overview
| Product Code | HJN |
|---|---|
| Device Name | Transilluminator, Battery-Powered |
| Regulation | 21 CFR 886.1945 |
| Device Class | Class 1 |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K941035 | VENOSCOPE | Trinity Partners, LLC | May 16, 1994 | SESE |
| K912747 | LULMITEX NEONATAL TRANSILLUMINATOR | Lumitex, Inc. | Dec 24, 1991 | SESE |
| K901309 | 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
