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 Powered Laser Surgical Instrument
510(k) Number K151655
Device Name CO2RE System
Applicant
Syneron Medical, Ltd.
Tavor Bldg., Industrial Zone, P.O.B. 550
Yokneam Illit,  IL 20692
Applicant Contact Ruthie Amir
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice M Hogan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/18/2015
Decision Date 09/15/2015
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
-
-