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FDA 510(k)

ARAMIS DERMATLOGIC LASER

K-Number: K012545 · 2001-11-05

ApplicantLumedics, Ltd.
Decision Date2001-11-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARAMIS DERMATLOGIC LASER is the device name listed in this FDA 510(k) record. The listed applicant is Lumedics, Ltd.. It received FDA 510(k) clearance on 2001-11-05 under 510(k) number K012545. 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 ARAMIS DERMATLOGIC LASER?

ARAMIS DERMATLOGIC LASER is a medical device that received FDA 510(k) clearance on 2001-11-05. The listed applicant is Lumedics, Ltd.. The 510(k) number is K012545.

When did ARAMIS DERMATLOGIC LASER receive FDA 510(k) clearance?

ARAMIS DERMATLOGIC LASER received FDA 510(k) clearance on 2001-11-05, under 510(k) number K012545.

Who is the listed applicant for ARAMIS DERMATLOGIC LASER?

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

What is the FDA product code for ARAMIS DERMATLOGIC LASER?

The FDA product code for ARAMIS DERMATLOGIC LASER is GEX. This falls under the Gastroenterology category.

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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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