Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015313684

FEI Number

3015313684

Entity Name

Mito Red Light LLC

City/State/Country

Scottsdale, AZ, US

Establishment Address

9319 N 94th Way, Ste 400, Scottsdale, AZ 85258, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Mito Red Light (Owner Number: 10080554)

Owner / Operator Contact Address

9319 N 94th Way, Ste 400, Scottsdale, AZ 85258, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240089

PMA Number

N/A

All Registered Proprietary Names

MitoGROW Mito Red Commercial Elite MitoPRO Series Mito Red Original Series MitoMOD Series Mito Mobile Mito Red Light Full Body Mat MitoPRO X Series MitoPOD Mito Red Advanced Red Light Therapy Belt MitoGREEN MitoGROW Pro Laser Helmet MitoBOOST Intranasal MitoADAPT 3 Series MitoQuad Wavelength Belt MitoPRO+ Series Mito Red Original 2 Series Mito Mobile Super MitoQUAD Wavelength Belt MitoADAPT Series MitoADAPT 2 Series Mito Red Light Helmet Mito Red Commercial Premiere MitoMIND Helmet Mito Mobile Flex MitoCLEAR Mask MitoGLOW Mask MitoRECHARGE Red Light Bed MitoPRO Mobile MitoCLEAR

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	2025-03-28
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2021-04-05
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-03-28
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-03-28
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-03-28

Official Correspondent

Scott Chaverri

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mito Red Light

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015313684. Last updated year: 2026. Please use registration number 3015313684 when referencing this establishment in official correspondence.