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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 NumberS036
Date Received06/23/2026
Decision Date07/21/2026
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  
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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