# OAY · Light Source System, Diagnostic Endoscopic

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/OAY

## Overview

- **Product Code:** OAY
- **Device Name:** Light Source System, Diagnostic Endoscopic
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

A fluorescence system intended for use as an adjunct to white light cystoscopy when used in combination with a photosensitizer for the detection of bladder cancer.  Patients with known or suspected bladder cancer and/or recurrence of bladder cancer, in patients undergoing diagnostic testing for bladder cancer by cystoscopy or positive urine cytology or who present with hematuria and/or a positive urine cytology test.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P050027](/device/P050027.md) | KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM | KARL STORZ Endoscopy-America, Inc. | May 28, 2010 | APPR |

## Top Applicants

- KARL STORZ Endoscopy-America, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/OAY](https://fda.innolitics.com/productcode/OAY)

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