Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MZ Skin LightMAX Supercharged LED Mask 2.0

K-Number: K213184 · 2021-11-23

ApplicantMz Skin
Decision Date2021-11-23
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MZ Skin LightMAX Supercharged LED Mask 2.0 is a medical device manufactured by Mz Skin. It received FDA 510(k) clearance on 2021-11-23 under approval number K213184. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MZ Skin LightMAX Supercharged LED Mask 2.0?

MZ Skin LightMAX Supercharged LED Mask 2.0 is a medical device that received FDA 510(k) clearance on 2021-11-23. It is manufactured by Mz Skin. The 510(k) number is K213184.

When was MZ Skin LightMAX Supercharged LED Mask 2.0 approved by the FDA?

MZ Skin LightMAX Supercharged LED Mask 2.0 received FDA 510(k) clearance on 2021-11-23, under approval number K213184.

What company makes MZ Skin LightMAX Supercharged LED Mask 2.0?

MZ Skin LightMAX Supercharged LED Mask 2.0 is manufactured by Mz Skin.

What is the FDA product code for MZ Skin LightMAX Supercharged LED Mask 2.0?

The FDA product code for MZ Skin LightMAX Supercharged LED Mask 2.0 is OLP.

Related Devices (Code: OLP)

K162371Pulsaderm ACE-All BlueNutra Luxe MD, LLC K162450ESPADA Acne-Clearing Blue Light PenForeo, Inc. K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC K160691Acne Light Therapy WandZuko, Inc. K160821Tria SapphireTria Beauty, Inc. K153081Clear Bi-LightMichael Todd, LP

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑