# ORZ: Eyelid Thermal Pulsation System

- Device class: 2; regulation: 21 CFR 886.5200; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 233 days (middle half 181–255)
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2023: 1
- 2024: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- DEN100017: Lipflow Thermal Pulsation System (Formerly Manual Mini System) (2011), cited by 3
- K133127: Lipiflow Thermal Pulsation System (2013), cited by 2
- K112704: Lipiflow Thermal Pulsation System (2011), cited by 2
- K231084: TearCare MGX System (2023), cited by 2
- K161357: LipiFlow Thermal Pulsation System (2016), cited by 2
- K172645: iLux Instrument, iLux Disposable (2017), cited by 2
- K192623: LipiFlow Thermal Pulsation System (2019), cited by 1
- K213045: TearCare System (2021), cited by 1
- K252409: TearCare MGX System (2026), cited by 1
- K242786: TearCare MGX System (2025), cited by 1

Source page: https://510kreport.com/product-code/ORZ
Data by year (CSV): https://510kreport.com/product-code/ORZ.csv