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FDA 510(k)

PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA

K-Number: K041323 · 2004-11-17

ApplicantNew Star Lasers, Inc.
Decision Date2004-11-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA 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 2004-11-17 under 510(k) number K041323. 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 PRIMA?

PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA is a medical device that received FDA 510(k) clearance on 2004-11-17. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K041323.

When did PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA receive FDA 510(k) clearance?

PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA received FDA 510(k) clearance on 2004-11-17, under 510(k) number K041323.

Who is the listed applicant for PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA?

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 PRIMA?

The FDA product code for PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA 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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