← Product Code [HKI](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI) · K954780

# KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C (K954780)

_Kowa Optimed, Inc. · HKI · Dec 1, 1995 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K954780

## Device Facts

- **Applicant:** Kowa Optimed, Inc.
- **Product Code:** [HKI](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI.md)
- **Decision Date:** Dec 1, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1120
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, 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/HKI/K954780](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K954780)

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