PMA P050027S033

Device: KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S033
Product code: OAY
Decision date: 2025-05-02
Classification: Gastroenterology, Urology
Generic name: Light source system, diagnostic endoscopic
Approval order statement: changes to remove the vibratory grinding step, changing to the polishing tool for the telescope lens, process changes to the camera head housing and strain relief with the aluminum material

Current openFDA PMA Record#

Device: KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S033
Product code: OAY
Generic name: Light source system, diagnostic endoscopic
Decision date: 2025-05-02
Decision code: OK30
Date received: 2025-04-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to remove the vibratory grinding step, changing to the polishing tool for the telescope lens, process changes to the camera head housing and strain relief with the aluminum material