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

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2026-05-12 under 510(k) 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. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K260415.

When did myLEDmask 2 (MJ-144) receive FDA 510(k) clearance?

myLEDmask 2 (MJ-144) received FDA 510(k) clearance on 2026-05-12, under 510(k) number K260415.

Who is the listed applicant for myLEDmask 2 (MJ-144)?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for myLEDmask 2 (MJ-144)?

The FDA product code for myLEDmask 2 (MJ-144) is OHS.

Other records listing Light Tree Ventures Europe B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253349Hair Regrowth Cap (Model: T-119-HRC)K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001K223893Infrared Heat (Model: E0221)K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)K230336CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)

View all 13 devices →

Related Devices (Code: OHS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

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.

↑