OND

Osmolality Of Tears

Product code

OND

Device name

Osmolality Of Tears

Device class

Class 1

21 CFR

21 CFR 862.1540

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).