COOL LIGHT 300— 510(k) K935423

Substantially Equivalent

Endosurgical Development Corp.

FDA 510(k) clearance K935423 for COOL LIGHT 300, Substantially Equivalent on 1994-01-26. Applicant: Endosurgical Development Corp..

Clearance details

Applicant: Endosurgical Development Corp.
Product code: Code GCT
Advisory panel: Gastroenterology, Urology
Date received: 1993-11-09
Decision date: 1994-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lomita, CA, US

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Adverse events under product code GCT

product code GCT

Malfunction: 1,393
Other: 2
Total: 1,395

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.