OAY · Light Source System, Diagnostic Endoscopic
· Class 3
Overview
| Product Code | OAY |
|---|---|
| Device Name | Light Source System, Diagnostic Endoscopic |
| Device Class | Class 3 |
| Review Panel |
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 | 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
