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FDA 510(k)

Theradome LH80 PRO

K-Number: K171775 · 2018-01-09

ApplicantTheradome, Inc.
Decision Date2018-01-09
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Theradome LH80 PRO is a medical device manufactured by Theradome, Inc.. It received FDA 510(k) clearance on 2018-01-09 under approval number K171775. 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 LH80 PRO?

Theradome LH80 PRO is a medical device that received FDA 510(k) clearance on 2018-01-09. It is manufactured by Theradome, Inc.. The 510(k) number is K171775.

When was Theradome LH80 PRO approved by the FDA?

Theradome LH80 PRO received FDA 510(k) clearance on 2018-01-09, under approval number K171775.

What company makes Theradome LH80 PRO?

Theradome LH80 PRO is manufactured by Theradome, Inc..

What is the FDA product code for Theradome LH80 PRO?

The FDA product code for Theradome LH80 PRO is OAP.

Other Devices by Theradome, Inc.

K161046Laser Helmet LH40-EVO K180460Theradome LH40

Related Devices (Code: OAP)

K162994Capillus302, Capillus312, Capillus352Capillus, LLC K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC K161046Laser Helmet LH40-EVOTheradome, Inc. K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC K152587DermaScalp Laser CapDermascalp, LLC

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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