PMA P050027S038

Device: Photodynamic Diagnostic D-Light C System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S038
Product code: OAY
Decision date: 2026-10-14
Classification: Gastroenterology, Urology
Generic name: Light source system, diagnostic endoscopic
Approval order statement: for reducing the curing time of the adhesive used at the distal end of the rigid endoscopes (27005AIA, 27005BIA, 27005CIA, and 27005FIA) from 60 minutes to 30 minutes

Current openFDA PMA Record#

Device: Photodynamic Diagnostic D-Light C System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S038
Product code: OAY
Generic name: Light source system, diagnostic endoscopic
Decision date: 2026-10-14
Decision code: OK30
Date received: 2026-09-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for reducing the curing time of the adhesive used at the distal end of the rigid endoscopes (27005AIA, 27005BIA, 27005CIA, and 27005FIA) from 60 minutes to 30 minutes