LIPIFLOW THERMAL PULSATION SYSTEM— 510(k) K112704
Substantially EquivalentTearscience, Inc.
FDA 510(k) clearance K112704 for LIPIFLOW THERMAL PULSATION SYSTEM, Substantially Equivalent on 2011-12-19. Applicant: Tearscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Tearscience, Inc.
- Product code
- Code ORZ
- Device class
- Class 2
- Regulation
- 21 CFR 886.5200
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
Recent devices under product code ORZ
view allMore clearances from Tearscience, Inc.
view allRecalls naming K112704
K-number listed on FDA's recall record- Z-1535-2017 — LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112704.
Data sourced from openFDA. This site is unofficial and independent of the FDA.