Definition: 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, I
| Device Type ID | 2219 |
| Device Name | Light Source System, Diagnostic Endoscopic |
| Physical State | System Includes A PPD Light Source, Specific PDD Telescopes For Cystoscopy), Camera System (PDD Camera Control Unit, And PDD Camera Heads) Fluid Light Cable, And PC Based Software Communication Program |
| Technical Method | 1. Excitation And Emission Filters In The PDD Telescopes And PDD Camera Heads Limit Light To The Blue Portion Of The Visible Spectrum The Combination Of These 2 Filters In Conjunction With The Photo- Fluorescent Drug Hexvix? Enables Visualization Of |
| Target Area | Urinary Bladder |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OAY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2219 |
| Device | Light Source System, Diagnostic Endoscopic |
| Product Code | OAY |
| FDA Device Classification | Class 3 Medical Device |