510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K083184Substantially Equivalent

Tearlab Osmolarity System

Ocusense, Inc., Philedelphia PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083184 is the FDA 510(k) clearance record for TEARLAB OSMOLARITY SYSTEM, a class I device, cleared for Ocusense, Inc. on under FDA product code OND (Osmolality Of Tears). FDA's definition for product code OND reads: "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". FDA records list one 510(k) clearance for Ocusense, Inc. As of , FDA records show no recalls naming K083184.

Clearance record

Decision date
Received
(198 days to decision)
Product code
OND Osmolality Of Tears
Regulation
21 CFR 862.1540
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Ocusense, Inc. 1835 Market St., 29th Floor, Philedelphia PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OND

Trailing 12 months

FDA records hold no clearances under product code OND in the trailing twelve months.

FDA records show no clearances under product code OND in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OND, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260