Light Source System, Diagnostic Endoscopic
The Light Source System, Diagnostic Endoscopic (product code OAY) is a fluorescence endoscopic light source system used as an adjunct to white light cystoscopy in combination with a photosensitizer for the detection of bladder cancer, indicated for patients with known or suspected bladder cancer, positive urine cytology, or hematuria. It is classified as FDA Class 3, requiring Premarket Approval (PMA), and is reviewed by the Gastroenterology and Urology panel. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OAY
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- GU
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.