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 K121471
Device Name LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS
Applicant
LIGHTSCALPEL LLC
16932 WOOD-RED RD NE STE 201
WOODINVILLE,  WA  98072
Applicant Contact GERALD S PALECKI
Correspondent
LIGHTSCALPEL LLC
16932 WOOD-RED RD NE STE 201
WOODINVILLE,  WA  98072
Correspondent Contact GERALD S PALECKI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/18/2012
Decision Date 07/10/2012
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
-
-