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

TPLC - Total Product Life Cycle

  • 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 Show TPLC since Back To Search Results
Device lens, contact (other material) - daily
Regulation Description Rigid gas permeable contact lens.
Product CodeHQD
Regulation Number 886.5916
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED VISION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BOSTON FOUNDATION FOR SIGHT
  SUBSTANTIALLY EQUIVALENT 1
CONTAMAC LTD.
  SUBSTANTIALLY EQUIVALENT 5
COOPERVISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON VISION SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
SYNERGEYES, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Adverse Event Without Identified Device or Use Problem 19
Appropriate Term/Code Not Available 12
Insufficient Information 3
Use of Device Problem 1
Difficult to Remove 1
Total Device Problems 36

Recalls
Manufacturer Recall Class Date Posted
1 Alden Optical III Sep-06-2018

-
-