Facility

Mito Red Light LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3015313684
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	9319 N 94th Way Scottsdale, AZ, US 85258
Registration status	Active · expires 2026
Parent company	Mito Red Light (owner-operator 10080554)
Brand names	MitoCLEAR

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (3)

Light Based Over The Counter Wrinkle Reduction
Product code OHS (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810
Over-The-Counter Powered Light Based Laser For Acne
Product code OLP (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810
Powered Laser Surgical Instrument
Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

Class IIOngoing2025-02-12
The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.

FDA inspections (1)

NAI2025-02-26
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Mito Red Light

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Mito Red Light LLC (FEI 3015313684) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015313684-mito-red-light-llc/

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