OAY — Light Source System, Diagnostic Endoscopic Class III
FDA product code OAY covers "Light Source System, Diagnostic Endoscopic", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OAY
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Unknown
- Implant
- No
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, 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.