Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Theradome, Inc.. It received FDA 510(k) clearance on 2016-05-12 under approval 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. It is manufactured by Theradome, Inc.. The 510(k) number is K161046.

When was Laser Helmet LH40-EVO approved by the FDA?

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

What company makes Laser Helmet LH40-EVO?

Laser Helmet LH40-EVO is manufactured by Theradome, Inc..

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

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

Other Devices by Theradome, Inc.

K180460Theradome LH40 K171775Theradome LH80 PRO

Related Devices (Code: OAP)

K162994Capillus302, Capillus312, Capillus352Capillus, LLC K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC K152587DermaScalp Laser CapDermascalp, LLC K153618Capillus202Capillus, 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.

↑