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FDA 510(k)

LASERPEEL SOFT-MET MODIFIED ERBIUM LASER

K-Number: K082028 · 2008-08-08

ApplicantGlobal USA Distribution, LLC
Decision Date2008-08-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERPEEL SOFT-MET MODIFIED ERBIUM 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 2008-08-08 under 510(k) number K082028. 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 LASERPEEL SOFT-MET MODIFIED ERBIUM LASER?

LASERPEEL SOFT-MET MODIFIED ERBIUM LASER is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Global USA Distribution, LLC. The 510(k) number is K082028.

When did LASERPEEL SOFT-MET MODIFIED ERBIUM LASER receive FDA 510(k) clearance?

LASERPEEL SOFT-MET MODIFIED ERBIUM LASER received FDA 510(k) clearance on 2008-08-08, under 510(k) number K082028.

Who is the listed applicant for LASERPEEL SOFT-MET MODIFIED ERBIUM 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 LASERPEEL SOFT-MET MODIFIED ERBIUM LASER?

The FDA product code for LASERPEEL SOFT-MET MODIFIED ERBIUM 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.

K083272SKINCLEAR Q-SWITCHED ND:YAG LASERK082033NANNOLIGHT INTENSE PULSED LIGHT SYSTEMK080697SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER

Related Devices (Code: GEX)

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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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