• 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 microscope, specular
Regulation Description AC-powered slitlamp biomicroscope.
Definition Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
Product CodeNQE
Regulation Number 886.1850
Device Class 2


Premarket Reviews
ManufacturerDecision
NIDEK CO
  SUBSTANTIALLY EQUIVALENT 2
NIDEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TOMEY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOPCON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Nidek Inc II Sep-01-2016

-
-