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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePhotodynamic Diagnostic D-Light C System
Generic NameLight source system, diagnostic endoscopic
ApplicantKARL STORZ Endoscopy-America, Inc.
2151 E. Grand Ave.
El Segundo, CA 90245
PMA NumberP050027
Supplement NumberS034
Date Received09/04/2025
Decision Date10/01/2025
Product Code OAY 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to replace the backside mirror coating from RSM 3950100 to RSM 3950108
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