OAY · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
OAY
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
GU
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.