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 K040563
Device Name LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)
Applicant
SANDSTONE MEDICAL TECHNOLOGIES, LLC
908 STETSON STREET
WOODLAND,  CA  95776
Applicant Contact CONNIE WHITE HOY
Correspondent
SANDSTONE MEDICAL TECHNOLOGIES, LLC
908 STETSON STREET
WOODLAND,  CA  95776
Correspondent Contact CONNIE WHITE HOY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/03/2004
Decision Date 10/08/2004
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
-
-