Data / Medical devices / United States / Mito Red Light LLC

Mito Red Light LLC: FDA-registered device maker in Scottsdale, AZ, United States, 3 510(k) clearances

Name: Mito Red Light LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mito Red Light LLC is registered with the FDA (registration 3015313684) in Scottsdale, AZ, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 10, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Mito Red Light LLC

FDA registration number: 3015313684
Address: 9319 N 94th Way Ste 400, Scottsdale, AZ, United States, 85258
Owner or operator: Mito Red Light (10080554)
Roles: Complaint file establishment, Specification developer
First device listed: April 5, 2021
Registered through: 2026
Brand names listed: Mito Mobile, Mito Mobile Flex, Mito Mobile Super, Mito Red Advanced Red Light Therapy Belt, Mito Red Commercial Elite, Mito Red Commercial Premiere, Mito Red Light Full Body Mat, Mito Red Light Helmet and more

Devices it lists

Device	Product code	Class	Role	Source
Lamp, Infrared, Therapeutic Heating	ILY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Complaint file establishment	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Complaint file establishment	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Complaint file establishment	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 10, 2024	K240089	Face Patches (MT-12MA, MT-12MC)	OHS	Substantially Equivalent	Shenzhen Kaiyan Medical Equipment Co., Ltd.	accessdata.fda.gov
December 20, 2022	K221775	LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)	OHS	Substantially Equivalent	Light Tree Ventures Europe B.V.	accessdata.fda.gov
November 18, 2022	K222477	Hair Growth Device	OAP	Substantially Equivalent	Dongguan Lescolton Medical Equipment Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 12, 2025	98999	Class II	Ongoing	Mito Red Light, Super Mobile	The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.	accessdata.fda.gov

Compare with other makers

Updated June 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.