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FDA 510(k)

EPLUS SKIN TREATMENT SYSTEM

K-Number: K113868 · 2012-06-11

ApplicantSyneron, Ltd.
Decision Date2012-06-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPLUS SKIN TREATMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Syneron, Ltd.. It received FDA 510(k) clearance on 2012-06-11 under 510(k) number K113868. 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 EPLUS SKIN TREATMENT SYSTEM?

EPLUS SKIN TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-11. The listed applicant is Syneron, Ltd.. The 510(k) number is K113868.

When did EPLUS SKIN TREATMENT SYSTEM receive FDA 510(k) clearance?

EPLUS SKIN TREATMENT SYSTEM received FDA 510(k) clearance on 2012-06-11, under 510(k) number K113868.

Who is the listed applicant for EPLUS SKIN TREATMENT SYSTEM?

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

What is the FDA product code for EPLUS SKIN TREATMENT SYSTEM?

The FDA product code for EPLUS SKIN TREATMENT SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Syneron, 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.

K110672ETWO SKIN TREATMENT SYSTEM

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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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