DeviceClearance

Product code OND— Clinical Chemistry

TEARLAB OSMOLARITY SYSTEM

Classification name
Osmolality Of Tears
Device class
Class 1
Regulation
21 CFR 862.1540
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

FDA classification definition

“To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.”

— U.S. Food and Drug Administration, device classification record for product code OND under 21 CFR 862.1540, via openFDA

Market context for product code OND

FDA has cleared 1 device under product code OND, all in 2009, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OND

Recent clearances under product code OND

Data sourced from openFDA. This site is unofficial and independent of the FDA.