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)

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)

K-Number: K260150 · 2026-04-22

ApplicantNOOANCE
Decision Date2026-04-22
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is a medical device manufactured by NOOANCE. It received FDA 510(k) clearance on 2026-04-22 under approval number K260150. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is a medical device that received FDA 510(k) clearance on 2026-04-22. It is manufactured by NOOANCE. The 510(k) number is K260150.

When was LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) approved by the FDA?

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) received FDA 510(k) clearance on 2026-04-22, under approval number K260150.

What company makes LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is manufactured by NOOANCE.

What is the FDA product code for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

The FDA product code for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is OHS.

Related Devices (Code: OHS)

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.