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FDA 510(k)

LASEMAR 800, 1000, 1500

K-Number: K092860 · 2010-07-16

ApplicantEufoton S.R.L.
Decision Date2010-07-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASEMAR 800, 1000, 1500 is the device name listed in this FDA 510(k) record. The listed applicant is Eufoton S.R.L.. It received FDA 510(k) clearance on 2010-07-16 under 510(k) number K092860. 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 LASEMAR 800, 1000, 1500?

LASEMAR 800, 1000, 1500 is a medical device that received FDA 510(k) clearance on 2010-07-16. The listed applicant is Eufoton S.R.L.. The 510(k) number is K092860.

When did LASEMAR 800, 1000, 1500 receive FDA 510(k) clearance?

LASEMAR 800, 1000, 1500 received FDA 510(k) clearance on 2010-07-16, under 510(k) number K092860.

Who is the listed applicant for LASEMAR 800, 1000, 1500?

The FDA 510(k) record lists Eufoton S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASEMAR 800, 1000, 1500?

The FDA product code for LASEMAR 800, 1000, 1500 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 Eufoton S.R.L. 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.

K260489LASEmaR 1500

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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