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FDA 510(k)

Theradome LH40

K-Number: K180460 · 2018-05-18

ApplicantTheradome, Inc.
Decision Date2018-05-18
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Theradome LH40 is the device name listed in this FDA 510(k) record. The listed applicant is Theradome, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180460. 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 Theradome LH40?

Theradome LH40 is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Theradome, Inc.. The 510(k) number is K180460.

When did Theradome LH40 receive FDA 510(k) clearance?

Theradome LH40 received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180460.

Who is the listed applicant for Theradome LH40?

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 Theradome LH40?

The FDA product code for Theradome LH40 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.

K171775Theradome LH80 PROK161046Laser Helmet LH40-EVO

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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