# Tearscience, Inc.

- Location (FDA's records): Morrisville, NC
- FDA decisions: 9 (2009–2019): 8 510(k) clearances and 1 De Novo grant
- Product codes: ORZ (5), HKI (4)
- Predicates its devices cite: 14 (11 its own); citations of its devices by later devices: 16 (11 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Optomed OY: 1 (https://510kreport.com/company/optomed)
- Mrp Group, Inc.: 1 (https://510kreport.com/company/mrp-group)
- Keeler Instruments, Inc.: 1 (https://510kreport.com/company/keeler-instruments)

## Firms that cite its devices most
- Kowa Co., Ltd.: 1 (https://510kreport.com/company/kowa)
- Tear Film Innovations, Inc.: 1 (https://510kreport.com/company/tear-film-innovations)
- United Integrated Services Co., Ltd.: 1 (https://510kreport.com/company/united-integrated-services)
- Sight Sciences, Inc.: 1 (https://510kreport.com/company/sight-sciences)
- Novoxel, Ltd.: 1 (https://510kreport.com/company/novoxel)

## Its most-cited devices
- K091935: Lipiview Ocular Surface Interferometer (2009), cited by 4
- DEN100017: Lipflow Thermal Pulsation System (Formerly Manual Mini System) (2011), cited by 3
- K112704: Lipiflow Thermal Pulsation System (2011), cited by 2
- K133127: Lipiflow Thermal Pulsation System (2013), cited by 2
- K161357: LipiFlow Thermal Pulsation System (2016), cited by 2
- K152869: LipiView II Ocular Surface Interferometer (2016), cited by 1

## Recent decisions
- K192623: LipiFlow Thermal Pulsation System (Oct 22, 2019)
- K182506: LipiScan Dynamic Meibomian Imager (Dec 10, 2018)
- K161357: LipiFlow Thermal Pulsation System (Nov 4, 2016)
- K152869: LipiView II Ocular Surface Interferometer (Jan 14, 2016)
- K133127: Lipiflow Thermal Pulsation System (Dec 23, 2013)
- K122481: Lipiview Ocular Surface Interferometer (Dec 31, 2012)
- K112704: Lipiflow Thermal Pulsation System (Dec 19, 2011)
- DEN100017: Lipflow Thermal Pulsation System (Formerly Manual Mini System) (Jun 28, 2011)

Source page: https://510kreport.com/company/tearscience