PEREGRINE DIFFUSION LIGHT PIPE
Device Facts
| Record ID | K950529 |
|---|---|
| Device Name | PEREGRINE DIFFUSION LIGHT PIPE |
| Applicant | Peregrine Surgical , Ltd. |
| Product Code | HJM · Ophthalmic |
| Decision Date | Jun 7, 1995 |
| 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.
