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 K130193
Device Name FRAXEL DUAL 1550/1927 LASER SYSTEM
Applicant
SOLTA MEDICAL, INC.
25881 INDUSTRIAL BLVD
HAYWARD,  CA  94545
Applicant Contact Raymond Lee
Correspondent
SOLTA MEDICAL, INC.
25881 INDUSTRIAL BLVD
HAYWARD,  CA  94545
Correspondent Contact Raymond Lee
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/25/2013
Decision Date 06/14/2013
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
-
-