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)

HairMax Laser

K-Number: K180885 · 2018-06-20

ApplicantLexington International, LLC
Decision Date2018-06-20
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HairMax Laser is a medical device manufactured by Lexington International, LLC. It received FDA 510(k) clearance on 2018-06-20 under approval number K180885. 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 HairMax Laser?

HairMax Laser is a medical device that received FDA 510(k) clearance on 2018-06-20. It is manufactured by Lexington International, LLC. The 510(k) number is K180885.

When was HairMax Laser approved by the FDA?

HairMax Laser received FDA 510(k) clearance on 2018-06-20, under approval number K180885.

What company makes HairMax Laser?

HairMax Laser is manufactured by Lexington International, LLC.

What is the FDA product code for HairMax Laser?

The FDA product code for HairMax Laser is OAP.

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.

↑