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 K950662
Device Name DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT
Applicant
LASERSCOPE
3052 ORCHARD DR.
SAN JOSE,  CA  95134 -2011
Applicant Contact DONNA PAGE
Correspondent
LASERSCOPE
3052 ORCHARD DR.
SAN JOSE,  CA  95134 -2011
Correspondent Contact DONNA PAGE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/13/1995
Decision Date 03/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-