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 Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K203214
Device Name DemarkQ WOW, DemarkQ POP
Applicant
Shenzhen Kaiyan Medical CO , Ltd.
40a Fuxin Rd., Fuyong Subdistrict,
Baoan District
Shenzhen,  CN 518000
Applicant Contact Alain Dijkstra
Correspondent
Shenzhen Kaiyan Medical CO , Ltd.
40a Fuxin Rd., Fuyong Subdistrict,
Baoan District
Shenzhen,  CN 518000
Correspondent Contact Alain Dijkstra
Regulation Number878.4810
Classification Product Code
OLP  
Date Received11/02/2020
Decision Date 07/22/2021
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
-
-