Atlas FDA

Photodynamic Diagnostic D-Light C (PDD) System

FDA premarket approval P050027/S035 · decided 2026-02-26

Approval details

PMA number
P050027
Supplement
S035
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Photodynamic Diagnostic D-Light C (PDD) System
Generic name
Light source system, diagnostic endoscopic
Applicant
KARL STORZ Endoscopy-America, Inc.
Date received
2026-01-29
Decision date
2026-02-26
Days to decision
28 days
Decision code
APPR
Product code
OAY
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
El Segundo, CA
Statement
specification for Photodynamic Diagnostic D-Light C (PDD) System light cables

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510(k) clearances by this applicant

RecordFirmDate
KARL STORZ Laryngoscopes and Accessories (K252624)KARL STORZ Endoscopy-America, Inc.2026-05-15
KARL STORZ Holders (K240506)Karl Storz Endoscopy America, Inc.2024-10-22
HOPKINS Telescopes (K223885)Karl Storz Endoscopy America, Inc.2023-09-14
KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- (K230359)Karl Storz Endoscopy America, Inc.2023-06-23
UNIDRIVE SIII System (K223520)Karl Storz-Endoscopy-America, Inc.2023-04-27
HOPKINS Telescopes (K223923)KARL STORZ Endoscopy-America, Inc.2023-03-30
KARL STORZ Bipolar Resectoscopes with HF Cable (K221893)Karl Storz Endoscopy America, Inc.2023-03-17
HOPKINS Telescopes (K221004)Karl Storz Endoscopy America, Inc.2022-12-20