DEN100017 is an FDA 510(k) submission for the LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM). This device is classified as a Eyelid Thermal Pulsation System (Class II - Special Controls, product code ORZ).
Submitted by Tearscience, Inc. (Morrisville, US). The FDA issued a Not Cleared (DENG) decision on June 28, 2011.
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 | DEN100017 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 09, 2010 |
| Decision Date | June 28, 2011 |
| Days to Decision | 323 days |
| Submission Type | Post-NSE |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| 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. |