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 Hair Removal
510(k) Number K232499
Device Name IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
Applicant
Shenzhen Lescolton Electrical Appliance Co., Ltd.
Rm. 301, Bldg. 04, # A3, Fourth Industrial Zone
Heshuikou Community, Matian St., Guangming District
Shenzhen,  CN 518105
Applicant Contact Chen Zhikui
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Gong Youshan
Regulation Number878.4810
Classification Product Code
OHT  
Date Received08/17/2023
Decision Date 10/11/2023
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
-
-