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FDA 510(k)

DEL SOL BLUE LIGHT THERAPY SYSTEM

K-Number: K061470 · 2006-07-20

ApplicantEdge Systems Corporation
Decision Date2006-07-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEL SOL BLUE LIGHT THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Edge Systems Corporation. It received FDA 510(k) clearance on 2006-07-20 under 510(k) number K061470. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEL SOL BLUE LIGHT THERAPY SYSTEM?

DEL SOL BLUE LIGHT THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-20. The listed applicant is Edge Systems Corporation. The 510(k) number is K061470.

When did DEL SOL BLUE LIGHT THERAPY SYSTEM receive FDA 510(k) clearance?

DEL SOL BLUE LIGHT THERAPY SYSTEM received FDA 510(k) clearance on 2006-07-20, under 510(k) number K061470.

Who is the listed applicant for DEL SOL BLUE LIGHT THERAPY SYSTEM?

The FDA 510(k) record lists Edge Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEL SOL BLUE LIGHT THERAPY SYSTEM?

The FDA product code for DEL SOL BLUE LIGHT THERAPY SYSTEM is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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