510(k) K172645
K172645 is an FDA 510(k) premarket notification submitted by Tear Film Innovations, Inc. for the device "iLux Instrument, iLux Disposable". The FDA issued a decision of Substantially Equivalent on December 26, 2017. The device falls under product code ORZ (Eyelid Thermal Pulsation System), a Class II device regulated under 21 CFR 886.5200. Tear Film Innovations, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 26, 2017
- Date Received
- September 1, 2017
- 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.