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FDA 510(k)

SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER

K-Number: K080697 · 2008-04-07

ApplicantGlobal USA Distribution, LLC
Decision Date2008-04-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Global USA Distribution, LLC. It received FDA 510(k) clearance on 2008-04-07 under 510(k) number K080697. 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 SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER?

SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER is a medical device that received FDA 510(k) clearance on 2008-04-07. The listed applicant is Global USA Distribution, LLC. The 510(k) number is K080697.

When did SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER receive FDA 510(k) clearance?

SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER received FDA 510(k) clearance on 2008-04-07, under 510(k) number K080697.

Who is the listed applicant for SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER?

The FDA 510(k) record lists Global USA Distribution, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER?

The FDA product code for SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Global USA Distribution, LLC 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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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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