Tearscience, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Tearscience, Inc.” (first 2009, latest 2019), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 139 |
| 2013 | 1 | 84 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 139 |
| 2017 | 0 | — |
| 2018 | 1 | 89 |
| 2019 | 1 | 29 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tearscience, Inc. took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ORZ | Eyelid Thermal Pulsation System | 5 | 4 |
| HKI | Camera, Ophthalmic, Ac-Powered | 4 | 4 |
Review panels
- Ophthalmic (9)
Most recent Tearscience, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192623 | LipiFlow Thermal Pulsation System | ORZ | 2019-10-22 | 29 |
| K182506 | LipiScan Dynamic Meibomian Imager | HKI | 2018-12-10 | 89 |
| K161357 | LipiFlow Thermal Pulsation System | ORZ | 2016-11-04 | 172 |
| K152869 | LipiView II Ocular Surface Interferometer | HKI | 2016-01-14 | 106 |
| K133127 | LIPIFLOW THERMAL PULSATION SYSTEM | ORZ | 2013-12-23 | 84 |
| K122481 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | HKI | 2012-12-31 | 139 |
| K112704 | LIPIFLOW THERMAL PULSATION SYSTEM | ORZ | 2011-12-19 | 94 |
| K091935 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | HKI | 2009-10-23 | 115 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN100017 | De Novo | Eyelid Thermal Pulsation System | 2011-06-28 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2017-01-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Tearscience, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02102464: Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers (Completed, started 2014-04)
- NCT01808560: Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery (Completed, started 2013-03)
- NCT01521507: Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye (Completed, started 2012-01)
- NCT01202747: Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction (Completed, started 2010-09)
- NCT00832130: Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye (Completed, started 2009-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tearscience, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Tearscience, Inc.” (first 2009, latest 2019), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tearscience, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tearscience, Inc. is 100 days.
Which FDA product codes appear under Tearscience, Inc.?
The most frequent FDA product codes under this applicant name are ORZ (Eyelid Thermal Pulsation System, 5); HKI (Camera, Ophthalmic, Ac-Powered, 4).
Next steps
- See all 8 Tearscience, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ORZ, Tearscience, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.