TearScience, Inc.
Milpitas, CA, US
TearScience, Inc. appears in FDA device records in Milpitas, CA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for TearScience, Inc. between 2009 and 2019. The busiest year on record is 2011, with 2. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2016 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192623 | LipiFlow Thermal Pulsation System | ORZ | Substantially Equivalent | |
| K182506 | LipiScan Dynamic Meibomian Imager | HKI | Substantially Equivalent | |
| K161357 | LipiFlow Thermal Pulsation System | ORZ | Substantially Equivalent | |
| K152869 | LipiView II Ocular Surface Interferometer | HKI | Substantially Equivalent | |
| K133127 | LIPIFLOW THERMAL PULSATION SYSTEM | ORZ | Substantially Equivalent | |
| K122481 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | HKI | Substantially Equivalent | |
| K112704 | LIPIFLOW THERMAL PULSATION SYSTEM | ORZ | Substantially Equivalent | |
| DEN100017 | LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) | ORZ | Unknown | |
| K091935 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | HKI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008169506 | 3008169506 | TearScience, Inc. | 510 Cottonwood Drive, Milpitas, CA 95035 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1535-2017 | LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile | Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration. | Class II | Terminated | |
| Z-0093-2017 | LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. | Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets TearScience, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain