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 K942439
Device Name ZEISS OPMILAS 144 SURGICAL LASERS
Applicant
Zeiss Humphrey System
2992 Alvarado St.
P.O. Box 5400
San Leandro,  CA  94577
Applicant Contact CHRISTOPHER TALBOT
Correspondent
Zeiss Humphrey System
2992 Alvarado St.
P.O. Box 5400
San Leandro,  CA  94577
Correspondent Contact CHRISTOPHER TALBOT
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/11/1994
Decision Date 07/01/1994
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
-
-