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 K221679
Device Name IPL Hair Remover, Model: G993, G996, G998 and G885
Applicant
Shenzhen Mywin Technology Co., Ltd.
2nd Floor, Bldg. B, New Age Gongrong Industrial Zone,
# 2, Shihuan Rd., Shilong Communit
Shenzhen,  CN
Applicant Contact Meiyun Liu
Correspondent
Guangzhou Keda Biological Tech Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Gaungzhou,  CN
Correspondent Contact Jet Li
Regulation Number878.4810
Classification Product Code
OHT  
Date Received06/09/2022
Decision Date 07/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-