• 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 K173843
Device Name illumiflow 148 Laser Cap
Applicant
EGlobal, LLC
10115 E Bell Rd
Suite 107
Scottsdale,  AZ  85260
Applicant Contact Wayne De Stefano
Correspondent
Liza Burns and Associates
6469 G Kawaihau Road
Kapaa,  HI  96746
Correspondent Contact Liza Burns
Regulation Number890.5500
Classification Product Code
OAP  
Date Received12/18/2017
Decision Date 01/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-