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FDA 510(k)

Laser Helmet LH40-EVO

K-Number: K161046 · 2016-05-12

ApplicantTheradome, Inc.
Decision Date2016-05-12
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Laser Helmet LH40-EVO is the device name listed in this FDA 510(k) record. The listed applicant is Theradome, Inc.. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K161046. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Laser Helmet LH40-EVO?

Laser Helmet LH40-EVO is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Theradome, Inc.. The 510(k) number is K161046.

When did Laser Helmet LH40-EVO receive FDA 510(k) clearance?

Laser Helmet LH40-EVO received FDA 510(k) clearance on 2016-05-12, under 510(k) number K161046.

Who is the listed applicant for Laser Helmet LH40-EVO?

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

What is the FDA product code for Laser Helmet LH40-EVO?

The FDA product code for Laser Helmet LH40-EVO is OAP.

Other records listing Theradome, Inc. 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.

K180460Theradome LH40K171775Theradome LH80 PRO

Related Devices (Code: OAP)

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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