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FDA 510(k)

ALMA LASERS ALEX755 MODULE

K-Number: K090571 · 2009-08-13

ApplicantAlma Lasers , Ltd.
Decision Date2009-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALMA LASERS ALEX755 MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers , Ltd.. It received FDA 510(k) clearance on 2009-08-13 under 510(k) number K090571. 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 ALMA LASERS ALEX755 MODULE?

ALMA LASERS ALEX755 MODULE is a medical device that received FDA 510(k) clearance on 2009-08-13. The listed applicant is Alma Lasers , Ltd.. The 510(k) number is K090571.

When did ALMA LASERS ALEX755 MODULE receive FDA 510(k) clearance?

ALMA LASERS ALEX755 MODULE received FDA 510(k) clearance on 2009-08-13, under 510(k) number K090571.

Who is the listed applicant for ALMA LASERS ALEX755 MODULE?

The FDA 510(k) record lists Alma Lasers , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALMA LASERS ALEX755 MODULE?

The FDA product code for ALMA LASERS ALEX755 MODULE is GEX. This falls under the Gastroenterology category.

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Other records listing Alma Lasers , Ltd. as applicant

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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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