myLEDmask 2 (MJ-144)
K-Number: K260415 · 2026-05-12
ApplicantLight Tree Ventures Europe B.V.
Decision Date2026-05-12
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
myLEDmask 2 (MJ-144) is a medical device manufactured by Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2026-05-12 under approval number K260415. 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 myLEDmask 2 (MJ-144)?
myLEDmask 2 (MJ-144) is a medical device that received FDA 510(k) clearance on 2026-05-12. It is manufactured by Light Tree Ventures Europe B.V.. The 510(k) number is K260415.
When was myLEDmask 2 (MJ-144) approved by the FDA?
myLEDmask 2 (MJ-144) received FDA 510(k) clearance on 2026-05-12, under approval number K260415.
What company makes myLEDmask 2 (MJ-144)?
myLEDmask 2 (MJ-144) is manufactured by Light Tree Ventures Europe B.V..
What is the FDA product code for myLEDmask 2 (MJ-144)?
The FDA product code for myLEDmask 2 (MJ-144) is 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.