PMA P050027

Device: Photodynamic Diagnostic D-Light C System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S030
Product code: OAY
Decision date: 2026-07-21
Generic name: Light source system, diagnostic endoscopic
Approval order statement: for the use of an automatic pneumatic Loctite applicator and new holding fixture. The change is being made to standardize the delivery of Loctite onto the grasping mechanism screws of the Image1 S HX-P Saphira Camera Head

Current openFDA PMA Record#

Device: Photodynamic Diagnostic D-Light C System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S036
Product code: OAY
Generic name: Light source system, diagnostic endoscopic
Decision date: 2026-07-21
Decision code: OK30
Date received: 2026-06-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for the use of an automatic pneumatic Loctite applicator and new holding fixture. The change is being made to standardize the delivery of Loctite onto the grasping mechanism screws of the Image1 S HX-P Saphira Camera Head