Karl Storz Photodynamic D-Light C (PDD) System

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Karl Storz Photodynamic D-Light C(Pdd) System -D-Light C Light Source

Trade Name

Karl Storz Photodynamic Diagnostic D-Light C (Pdd) System

Generic Name

Light source system, diagnostic endoscopic

PMA Number

P050027 ↗

FDA Product Code

OAY

Device Class

Class III

Advisory Committee

Gastroenterology, Urology

FDA Decision

APPR Approved

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  Class II

  FDA 510(k) K252624 Active Cleared 15 May 2026

• Ksea Dion-Gracia Set

  Class II

  FDA 510(k) K010785 Active Cleared 21 Aug 2001

• Karl Storz Slotted Whisker Arthroscopic Blade

  Class II

  FDA 510(k) K963029 Active Cleared 27 Nov 1996

• Storz SLX-F2 Storm Touch

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  FDA 510(k) K070579 Active Cleared 30 Aug 2007

• Karl Storz Micro-Instrument for Cochlear Implantation

  Class I

  FDA 510(k) K946332 Active Cleared 5 Jun 1995

• Flexible Video-Uretero-Renoscope System Open recall

  Class II

  FDA 510(k) K131369 Active Cleared 26 Nov 2013

See all devices from Karl Storz Endoscopy-America, Inc. →

• What clinical procedure is the Karl Storz Photodynamic D-Light C (PDD) System specifically designed to assist with, and how does it work?

  The Karl Storz Photodynamic D-Light C (PDD) System is designed to assist in photodynamic diagnosis during cystoscopy, specifically for detecting non-muscle invasive papillary cancer of the bladder. It works in combination with the drug CYSVIEW (hexaminolevulinate hydrochloride), which is administered intravesically. When activated by the PDD System’s blue light, CYSVIEW fluoresces, enhancing the visibility of bladder lesions that may not be visible under standard white light cystoscopy.

• Is the Karl Storz Photodynamic D-Light C (PDD) System intended for use in other specialties besides urology, and if so, how?

  While the system is primarily approved for urology—specifically for photodynamic blue-light cystoscopy—it is also authorized for use in gastroenterology settings. However, its clinical application in gastroenterology is not detailed in the data, and its use there is not explicitly indicated for any specific procedure. The system’s role in gastroenterology would likely be limited to diagnostic endoscopic imaging where photodynamic diagnosis could theoretically apply, though this is not a stated indication.

• How is the Karl Storz Photodynamic D-Light C (PDD) System supplied, and is it reusable or single-use?

  The Karl Storz Photodynamic D-Light C (PDD) System is supplied as a reusable medical device. This means it is designed for repeated use after proper cleaning, disinfection, and maintenance in accordance with manufacturer guidelines, rather than being intended for single-use disposal.

• What regulatory pathway was followed for the approval of the Karl Storz Photodynamic D-Light C (PDD) System, and what does this mean for its use?

  The system was approved through the FDA’s Premarket Approval (PMA) process, specifically under PMA number P050027. This pathway is typically used for high-risk medical devices like Class III devices, ensuring rigorous evaluation of safety and effectiveness before approval. Clinically, this means the system has undergone comprehensive review by the FDA to confirm its intended use—photodynamic diagnosis of bladder cancer in conjunction with CYSVIEW—is safe and effective for the specified indications.