510(k) K083184
K083184 is an FDA 510(k) premarket notification submitted by Ocusense, Inc. for the device "TEARLAB OSMOLARITY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 14, 2009. The device falls under product code OND (Osmolality Of Tears), a Class I device regulated under 21 CFR 862.1540.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2009
- Date Received
- October 28, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Osmolality Of Tears
- Device Class
- Class I
- Regulation Number
- 862.1540
- Review Panel
- CH
- Submission Type
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.