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FDA 510(k)

ME HAIR2GO

K-Number: K121598 · 2012-10-12

Decision Date2012-10-12
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ME HAIR2GO is the device name listed in this FDA 510(k) record. The listed applicant is Syneron Medical, Ltd.. It received FDA 510(k) clearance on 2012-10-12 under 510(k) number K121598. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ME HAIR2GO?

ME HAIR2GO is a medical device that received FDA 510(k) clearance on 2012-10-12. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K121598.

When did ME HAIR2GO receive FDA 510(k) clearance?

ME HAIR2GO received FDA 510(k) clearance on 2012-10-12, under 510(k) number K121598.

Who is the listed applicant for ME HAIR2GO?

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

What is the FDA product code for ME HAIR2GO?

The FDA product code for ME HAIR2GO is ONF.

Other records listing Syneron Medical, 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.

View all 31 devices →

Related Devices (Code: ONF)

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.

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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