K192623 is an FDA 510(k) clearance for the LipiFlow Thermal Pulsation System. This device is classified as a Eyelid Thermal Pulsation System (Class II - Special Controls, product code ORZ).
Submitted by Tearscience, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 22, 2019, 29 days after receiving the submission on September 23, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5200. Therapeutic Application Of Heat And Massage To The Eyelids..
| 510(k) Number | K192623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2019 |
| Decision Date | October 22, 2019 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | ORZ - Eyelid Thermal Pulsation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5200 |
| Definition | Therapeutic Application Of Heat And Massage To The Eyelids. |