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FDA 510(k)

CLAROS DENTAL LASER SYSTEM

K-Number: K063152 · 2007-03-07

ApplicantElexxion AG
Decision Date2007-03-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLAROS DENTAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elexxion AG. It received FDA 510(k) clearance on 2007-03-07 under 510(k) number K063152. 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 CLAROS DENTAL LASER SYSTEM?

CLAROS DENTAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-07. The listed applicant is Elexxion AG. The 510(k) number is K063152.

When did CLAROS DENTAL LASER SYSTEM receive FDA 510(k) clearance?

CLAROS DENTAL LASER SYSTEM received FDA 510(k) clearance on 2007-03-07, under 510(k) number K063152.

Who is the listed applicant for CLAROS DENTAL LASER SYSTEM?

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

What is the FDA product code for CLAROS DENTAL LASER SYSTEM?

The FDA product code for CLAROS DENTAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Elexxion AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081652CLAROS NANO DENTAL LASER SYSTEM

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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