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 K883379
Device Name MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2
Applicant
Heraeus Lasersonics, Inc.
3420 Central Expy.
P.O. Box 58005
Santa Clara,  CA  95051
Applicant Contact CHARLES L ROSE
Correspondent
Heraeus Lasersonics, Inc.
3420 Central Expy.
P.O. Box 58005
Santa Clara,  CA  95051
Correspondent Contact CHARLES L ROSE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/10/1988
Decision Date 01/24/1989
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
Predetermined Change
Control Plan Authorized		 No
-
-