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 Refractometer, Ophthalmic
510(k) Number K000327
Device Name WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
Applicant
Visx, Incorporated
3400 Central Expy.
Santa Ana,  CA  95051
Applicant Contact DAVID M PATINO
Correspondent
Visx, Incorporated
3400 Central Expy.
Santa Ana,  CA  95051
Correspondent Contact DAVID M PATINO
Regulation Number886.1760
Classification Product Code
HKO  
Date Received02/02/2000
Decision Date 05/02/2000
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-