PMA P050027S028

Device: KARL STORZ D-Light C PDD System
Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: OAY
Decision date: 2022-02-04
Generic name: Light source system, diagnostic endoscopic
Approval order statement: Approval for the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System. The device is for use in combination with the optical imaging drug Cysview® (hexaminolevulinate hydrochloride) for Intravesical Solution is indicated for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasive bladder cancer, including carcinoma in situ (CIS), in patients suspected or known to have the lesion on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for bladder cancer.

Current openFDA PMA Record#

Device: KARL STORZ D-Light C PDD System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S028
Product code: OAY
Generic name: Light source system, diagnostic endoscopic
Decision date: 2022-02-04
Decision code: APPR
Date received: 2021-07-20
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System. The device is for use in combination with the optical imaging drug Cysview® (hexaminolevulinate hydrochloride) for Intravesical Solution is indicated for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasive bladder cancer, including carcinoma in situ (CIS), in patients suspected or known to have the lesion on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for bladder cancer.