510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K935423Substantially Equivalent

Cool Light 300

Endosurgical Development Corp., Lomita CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935423 is the FDA 510(k) clearance record for COOL LIGHT 300, a class II device, cleared for Endosurgical Development Corp. on under FDA product code GCT (Light Source, Endoscope, Xenon Arc). FDA records list one 510(k) clearance for Endosurgical Development Corp. As of , FDA records show no recalls naming K935423.

Clearance record

Decision date
Received
(78 days to decision)
Product code
GCT Light Source, Endoscope, Xenon Arc
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Endosurgical Development Corp. 1985 Rolling Vista Dr., Lomita CA
510(k) summary
Statement
Third party review
No

Clearances, product code GCT

Trailing 12 months

FDA records hold no clearances under product code GCT in the trailing twelve months.

FDA records show no clearances under product code GCT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260