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FDA 510(k)

SIROLASER

K-Number: K053161 · 2006-01-18

ApplicantSirona Dental Systems GmbH
Decision Date2006-01-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIROLASER is the device name listed in this FDA 510(k) record. The listed applicant is Sirona Dental Systems GmbH. It received FDA 510(k) clearance on 2006-01-18 under 510(k) number K053161. 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 SIROLASER?

SIROLASER is a medical device that received FDA 510(k) clearance on 2006-01-18. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K053161.

When did SIROLASER receive FDA 510(k) clearance?

SIROLASER received FDA 510(k) clearance on 2006-01-18, under 510(k) number K053161.

Who is the listed applicant for SIROLASER?

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

What is the FDA product code for SIROLASER?

The FDA product code for SIROLASER is GEX. This falls under the Gastroenterology category.

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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

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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