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FDA 510(k)

TATTOOSTAR EFFECT Y

K-Number: K112669 · 2012-05-11

ApplicantAsclepion Laser Technologies GmbH
Decision Date2012-05-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TATTOOSTAR EFFECT Y is the device name listed in this FDA 510(k) record. The listed applicant is Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2012-05-11 under 510(k) number K112669. 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 TATTOOSTAR EFFECT Y?

TATTOOSTAR EFFECT Y is a medical device that received FDA 510(k) clearance on 2012-05-11. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K112669.

When did TATTOOSTAR EFFECT Y receive FDA 510(k) clearance?

TATTOOSTAR EFFECT Y received FDA 510(k) clearance on 2012-05-11, under 510(k) number K112669.

Who is the listed applicant for TATTOOSTAR EFFECT Y?

The FDA 510(k) record lists Asclepion Laser Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TATTOOSTAR EFFECT Y?

The FDA product code for TATTOOSTAR EFFECT Y is GEX. This falls under the Gastroenterology category.

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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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