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 K172555
Device Name SAPPHIRE, ELEVARE SAPPHIRE
Applicant
Omm Imports, Inc. D/B/A Zero Gravity
9737 NW 41st St.
Doral,  FL  33178
Applicant Contact Zivan Habibi
Correspondent
Aegis, Inc.
2424 Dempster Dr.
Coralville,  IA  52241
Correspondent Contact Susan Anthoney-DeWet
Regulation Number878.4810
Classification Product Code
OLP  
Date Received08/24/2017
Decision Date 05/01/2018
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
-
-