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 Fat Reducing Low Level Laser
510(k) Number K170709
Device Name CURVE Laser System
Applicant
Yolo Medical, Inc.
1959 152nd St., Suite 245
Surrey,  CA v4a 9e3
Applicant Contact Robert Krznaric
Correspondent
Rockin' Regulatory, Inc.
21831 Tumbleweed Cir.
Lake Forest,  CA  92630
Correspondent Contact Paul Kramsky
Regulation Number878.5400
Classification Product Code
OLI  
Date Received03/08/2017
Decision Date 06/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02909790
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-