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FDA 510(k)

PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300

K-Number: K024259 · 2003-06-20

ApplicantNew Star Lasers, Inc.
Decision Date2003-06-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 is the device name listed in this FDA 510(k) record. The listed applicant is New Star Lasers, Inc.. It received FDA 510(k) clearance on 2003-06-20 under 510(k) number K024259. 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 PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300?

PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 is a medical device that received FDA 510(k) clearance on 2003-06-20. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K024259.

When did PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 receive FDA 510(k) clearance?

PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 received FDA 510(k) clearance on 2003-06-20, under 510(k) number K024259.

Who is the listed applicant for PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300?

The FDA 510(k) record lists New Star Lasers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300?

The FDA product code for PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

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

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