The Dry Eye Zone

Rebecca's Blog


Device news: TearLab gets FDA clearance

TearLab Corporation Announces FDA 510(k) Clearance of the TearLab(tm) Osmolarity System
May 19, 2009
Global Newswire

SAN DIEGO, May 19, 2009 (GLOBE NEWSWIRE) -- OccuLogix, Inc. dba TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) an ophthalmic, in-vitro diagnostics company, today announced FDA 510(k) clearance of its award winning TearLab Osmolarity System. The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the diagnosis of patients with signs or symptoms of Dry Eye Disease (DED), in conjunction with other methods of clinical evaluation. The 510(k) clearance allows the Company to immediately begin market activities in the U.S. to clinical facilities categorized as high or moderate complex under the Clinical Laboratory Improvement Act of 1988 (CLIA '88).