Photodynamic Diagnostic D-Light C System
FDA premarket approval P050027/S034 · decided 2025-10-01
Approval details
- PMA number
- P050027
- Supplement
- S034
- 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
- 2025-09-04
- Decision date
- 2025-10-01
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- to replace the backside mirror coating from RSM 3950100 to RSM 3950108
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