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 K212881
Device Name Intense Pulsed Light (IPL) System
Applicant
Shenzhen Fansizhe Science and Technology Co., Ltd.
2nd And 3rd Floors, # 17, Xinfa 2nd Rd., Xinqiao
Community, Xinqiao St., Baoan District
Shenzhen,  CN 518125
Applicant Contact Cheng Endang
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm. 1711 Bldg. K, No 101 Science Ave.
International Creative Valley Development Zone
Guangzhou,  CN
Correspondent Contact Jet You
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
ONF  
Date Received09/10/2021
Decision Date 04/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-