← Product Code [HJM](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM) · K940393

# PEREGRINE WIDE ANGLE LIGHT PIPE (K940393)

_Peregrine Surgical , Ltd. · HJM · Sep 2, 1994 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K940393

## Device Facts

- **Applicant:** Peregrine Surgical , Ltd.
- **Product Code:** [HJM](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM.md)
- **Decision Date:** Sep 2, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1945
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K940393](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJM/K940393)

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