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 K242789
Device Name Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
Applicant
Dongguan Laiguang Electronic Technology Co., Ltd.
Rm.201,#64,Dongkangroad,Dalingshantown
Dongguan,  CN 523820
Applicant Contact Jiangxiang Wu
Correspondent
Dongguan Laiguang Electronic Technology Co., Ltd.
Rm.201,#64,Dongkangroad,Dalingshantown
Dongguan,  CN 523820
Correspondent Contact Jiangxiang Wu
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received09/16/2024
Decision Date 01/02/2025
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
-
-