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 K070284
Device Name FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)
Applicant
Reliant Technologies, Inc.
464 Ellis St.
Mountain View,  CA  94043
Applicant Contact HEATHER MACFALLS
Correspondent
Reliant Technologies, Inc.
464 Ellis St.
Mountain View,  CA  94043
Correspondent Contact HEATHER MACFALLS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/29/2007
Decision Date 05/17/2007
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
-
-