• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name powered laser surgical instrument
510(k) Number K932883
Device Name OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM
Original Applicant
TRIMEDYNE, INC.
2801 barranca rd.
irvine,  CA  92714 -5114
Original Contact victor ham
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/14/1993
Decision Date 06/21/1994
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
-
-