510(k) K091935
K091935 is an FDA 510(k) premarket notification submitted by Tearscience, Inc. for the device "LIPIVIEW OCULAR SURFACE INTERFEROMETER". The FDA issued a decision of Substantially Equivalent on October 23, 2009. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Tearscience, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2009
- Date Received
- June 30, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type