• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • 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
Classification Nameaccessories, soft lens products
Generic Namedaily protein remover (contact lens cleaner)
Regulation Number886.5928
PMA NumberP820001
Supplement NumberS022
Date Received03/04/1997
Decision Date07/02/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to allow for the use of alcon multi-purpose solution id 81573 (opti-one multi-purpose solution) as an alternate diluent for opti-free(r) supraclens(r) daily protein remover.