Photodynamic Diagnostic D-Light C System
FDA premarket approval P050027/S036 · decided 2026-07-21
Approval details
- PMA number
- P050027
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Photodynamic Diagnostic D-Light C System
- Generic name
- Light source system, diagnostic endoscopic
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2026-06-23
- Decision date
- 2026-07-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- 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
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