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 K230090
Device Name Diode Laser Hair Removal
Applicant
Wuhan Lotuxs Technology Co., Ltd.
501/E2, Future City, No.999 high-tech avenue
Wuhan 430206, China(Free Trade Zone/Wuhan Area)
Wuhan,  CN 430075
Applicant Contact Na Wu
Correspondent
Tacro Guangzhou Branch
501/E2, Future city, No.999 High-Tech Avenue
(Free Trade Zone/Wuhan Area)
Wuhan,  CN 430206
Correspondent Contact Na Wu
Regulation Number878.4810
Classification Product Code
OHT  
Date Received01/12/2023
Decision Date 04/19/2023
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
-
-