Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K260415
Device Name myLEDmask 2 (MJ-144)
Applicant
Light Tree Ventures Europe B.V.
Unit 2.01 Saturnusstraat 95
Den Haag,  NL 2516AG
Applicant Contact Kim Markwat
Correspondent
Light Tree Ventures Europe B.V.
Unit 2.01 Saturnusstraat 95
Den Haag,  NL 2516AG
Correspondent Contact Alain Dijkstra
Regulation Number878.4810
Classification Product Code
OHS  
Date Received02/09/2026
Decision Date 05/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-