510(k) K133127
K133127 is an FDA 510(k) premarket notification submitted by Tearscience, Inc. for the device "LIPIFLOW THERMAL PULSATION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 23, 2013. The device falls under product code ORZ (Eyelid Thermal Pulsation System), a Class II device regulated under 21 CFR 886.5200. Tearscience, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2013
- Date Received
- September 30, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eyelid Thermal Pulsation System
- Device Class
- Class II
- Regulation Number
- 886.5200
- Review Panel
- OP
- Submission Type
Therapeutic application of heat and massage to the eyelids.