OND — Osmolality Of Tears Class I
FDA product code OND covers "Osmolality Of Tears", a Class I medical device regulated under 21 CFR 862.1540. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OND
- Device Class
- Class I
- Regulation Number
- 862.1540
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K083184 | ocusense | TEARLAB OSMOLARITY SYSTEM | May 14, 2009 |