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FDA 510(k)

CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES

K-Number: K043319 · 2004-12-17

ApplicantNovalis Medical, LLC
Decision Date2004-12-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Novalis Medical, LLC. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K043319. 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 CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES?

CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Novalis Medical, LLC. The 510(k) number is K043319.

When did CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES receive FDA 510(k) clearance?

CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES received FDA 510(k) clearance on 2004-12-17, under 510(k) number K043319.

Who is the listed applicant for CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES?

The FDA 510(k) record lists Novalis Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES?

The FDA product code for CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES 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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