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 K214113
Device Name Hand-held IPL device(JOVS Graphene Hair Removal Device)
Applicant
Shenzhen Qianyu Technology Co., Ltd.
Rm. 1002, Bldg. A2, Kexing Science Park, #15
Keyuan Rd., Nanshan District
Shenzhen,  CN 518057
Applicant Contact Kunming Lin
Correspondent
Guangzhou Tianke Testing Technology Service Co., Ltd.
Rm. 106-1, 1st Floor, Bldg. A, # 1, Xin'An Rd.,
Yonghe Economic Zone, Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Klem Hou
Regulation Number878.4810
Classification Product Code
OHT  
Date Received12/30/2021
Decision Date 03/28/2022
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
-
-