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FDA 510(k)

ETWO SKIN TREATMENT SYSTEM

K-Number: K110672 · 2011-10-03

ApplicantSyneron, Ltd.
Decision Date2011-10-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ETWO 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 2011-10-03 under 510(k) number K110672. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETWO SKIN TREATMENT SYSTEM?

ETWO SKIN TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-03. The listed applicant is Syneron, Ltd.. The 510(k) number is K110672.

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

ETWO SKIN TREATMENT SYSTEM received FDA 510(k) clearance on 2011-10-03, under 510(k) number K110672.

Who is the listed applicant for ETWO 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 ETWO SKIN TREATMENT SYSTEM?

The FDA product code for ETWO SKIN TREATMENT SYSTEM is GEI.

Related Clinical Trials

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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.

K113868EPLUS SKIN TREATMENT SYSTEM

Related Devices (Code: GEI)

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Official Source

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