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 K932062
Device Name OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR
Applicant
Alcon Laboratories
6201 S. Fwy. R7-14
Fort Worth,  TX  76134
Applicant Contact DAVID W KRAPF
Correspondent
Alcon Laboratories
6201 S. Fwy. R7-14
Fort Worth,  TX  76134
Correspondent Contact DAVID W KRAPF
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HQF  
Date Received04/29/1993
Decision Date 03/18/1994
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
Predetermined Change
Control Plan Authorized		 No
-
-