Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006182775

FEI Number

3006182775

Entity Name

Hairmax International LLC

City/State/Country

Boca Raton, FL, US

Establishment Address

1040 HOLLAND DR, Boca Raton, FL 33487, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

HAIRMAX INTERNATIONAL, LLC (Owner Number: 9055586)

Owner / Operator Contact Address

1040 Holland Drive, --, Boca Raton, FL 33487, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180885

PMA Number

N/A

All Registered Proprietary Names

HairMax LaserComb Ultima 9 HairMax LaserComb Ultima 12 HairMax Professional 12 Hairmax LaserComb Ultima 12 Classic Hairmax LaserComb Ultima 9 Classic Actonis 18 Dual Action Hairmax LaserBand 41 ComfortFlex HairMax LaserBand 82 Hairmax LaserBand 82 ComfortFlex Hairmax LaserComb Ultima 12 Classic Hairmax LaserComb Ultima 9 Classic HairMax Professional 12 Actonis 18 Dual Action HairMax LaserComb Ultima 9 HairMax LaserComb Ultima 12 Hairmax Lumina 272 HairMax Laser 202 HairMax Laser 272 HairMax Laser 80 RegrowMD 272

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2015-08-27
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2014-12-15
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2013-01-21
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2025-07-24
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2018-07-12

Official Correspondent

Jose Robert

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HAIRMAX INTERNATIONAL, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006182775. Last updated year: 2026. Please use registration number 3006182775 when referencing this establishment in official correspondence.