VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
Device Facts
| Record ID | K893170 |
|---|---|
| Device Name | VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) |
| Applicant | Keeler Instruments, Inc. |
| Product Code | HJM · Ophthalmic |
| Decision Date | Jun 5, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1945 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
