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 K923896
Device Name HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS
Applicant
Heraeus Lasersonics, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035
Applicant Contact ROBERT MILDER
Correspondent
Heraeus Lasersonics, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035
Correspondent Contact ROBERT MILDER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/04/1992
Decision Date 11/25/1992
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
-
-