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 laser, comb, hair
510(k) Number K181878
Device Name Kiierr 272 Laser, Kiierr 148 Laser
Applicant
Kiierr International, LLC
863 East Downington Avenue
Salt Lake City,  UT  84105 -3211
Applicant Contact Michael Anderson
Correspondent
NST Consultants, Inc
641 Shunpike Road, Suite 311
Chatham,  NJ  07928
Correspondent Contact Raymond R. Blanche
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/13/2018
Decision Date 09/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-