# DEN100017: Lipflow Thermal Pulsation System (Formerly Manual Mini System)

- Pathway: De Novo (Post-NSE)
- Applicant: Tearscience, Inc.
- Decided: Jun 28, 2011 after 323 days
- Product code: ORZ (Eyelid Thermal Pulsation System)
- Device class: 2
- Regulation: 21 CFR 886.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K112704: Lipiflow Thermal Pulsation System (2011), 11 descendants of its own
- K133127: Lipiflow Thermal Pulsation System (2013), 10 descendants of its own
- K161357: LipiFlow Thermal Pulsation System (2016), 7 descendants of its own
- K213045: TearCare System (2021), 5 descendants of its own
- K231084: TearCare MGX System (2023), 4 descendants of its own

Source page: https://510kreport.com/device/DEN100017
Methodology: https://510kreport.com/methodology