Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010123655

FEI Number

3010123655

Entity Name

Curallux, LLC

City/State/Country

Miami, FL, US

Establishment Address

1715 NW 82nd Ave, Miami, FL 33126, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Curallux LLC (Owner Number: 10048618)

Owner / Operator Contact Address

1715 NW 82nd Ave, Miami, FL 33126, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143199

PMA Number

N/A

All Registered Proprietary Names

CapillusPlus S1 CapillusPlus Capillus One Capillus One S CuraviUltraLite CuraviPlus CuraviPro CuraviUltra Capillus Pro S1 CapillusRx, Capillus Spectrum Capillus Rx Duo Capillus OfficePro Capillus MD Duo Capillus Pro S2 CapillusRx, Capillus Spectrum, Capillus TriSpectrum CapillusPro

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	2016-02-17
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2019-11-19
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2015-06-15
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2017-02-13
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2015-02-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Curallux 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 3010123655. Last updated year: 2026. Please use registration number 3010123655 when referencing this establishment in official correspondence.