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FDA 510(k)

ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM

K-Number: K072564 · 2008-05-23

ApplicantAlma Lasers , Ltd.
Decision Date2008-05-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM 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 2008-05-23 under 510(k) number K072564. 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 HARMONY XL MULTI-APPLICATION PLATFORM?

ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM is a medical device that received FDA 510(k) clearance on 2008-05-23. The listed applicant is Alma Lasers , Ltd.. The 510(k) number is K072564.

When did ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM receive FDA 510(k) clearance?

ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM received FDA 510(k) clearance on 2008-05-23, under 510(k) number K072564.

Who is the listed applicant for ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM?

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 HARMONY XL MULTI-APPLICATION PLATFORM?

The FDA product code for ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM is GEX. This falls under the Gastroenterology category.

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Other records listing Alma Lasers , Ltd. 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.

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Related Devices (Code: GEX)

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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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