Cool Light 300
by Endosurgical Development Corp.
510(k) K935423
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935423 | Date26 Jan 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GCT
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Cool Light 300 is a xenon arc light source designed for endoscopic procedures. It provides illumination for visualisation during gastrointestinal and urological examinations, ensuring clear visibility of internal tissues and structures.
This device is intended for use in clinical settings, supplied as a reusable medical instrument. It operates under FDA 510(k) clearance (K935423) and is classified as a Class II device under regulation 876.1500. No specific sterility or MRI safety information is provided in the data.
Questions
AI-generated answers, 19 Sep 2026
What types of endoscopic procedures is the Cool Light 300 primarily used for, and why is its illumination important in these settings?
The Cool Light 300 is designed for gastrointestinal and urological endoscopic procedures, providing clear illumination of internal tissues and structures. Its xenon arc light source ensures high-intensity, consistent illumination, which is critical for visualizing fine details during examinations like colonoscopies, cystoscopies, or upper GI endoscopies, where visibility directly impacts diagnostic accuracy and procedural safety.
Is the Cool Light 300 a single-use or reusable device, and what does this mean for maintenance and cost considerations?
The Cool Light 300 is explicitly described as a reusable medical instrument. This means it is built for repeated use across multiple procedures, reducing per-procedure costs. However, it requires proper cleaning, disinfection, and maintenance between uses to ensure reliability and prevent contamination, which may involve additional operational workflows or service contracts with the manufacturer.
How do I determine if the Cool Light 300 is compatible with my existing endoscopic equipment, and what regulatory pathway was followed for its approval?
The Cool Light 300 is classified under FDA product code GCT and was cleared via a 510(k) submission (K935423) with a substantially equivalent (SESE) determination, meaning it was compared to a legally marketed predecessor. Its compatibility with endoscopic systems depends on the manufacturer’s specifications for connectors, power requirements, and integration protocols—details that should be verified with Endosurgical Development Corp. The device is not explicitly labeled as MRI-safe, so caution is advised in MRI environments.
Are there specific storage requirements for the Cool Light 300 to maintain its performance and longevity?
While the provided data does not specify exact storage conditions, reusable medical devices like the Cool Light 300 generally require protection from extreme temperatures, humidity, and physical damage. Manufacturers typically recommend storing the device in a clean, dry environment, away from direct sunlight or sources of electromagnetic interference, to preserve its optical and electrical components. Always refer to the manufacturer’s instructions for detailed guidance.