meddevicedb.com FDA Device Reference

LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)

DEN100017 Class II Post-NSE
Decision Date
2011-06-28
Sponsor / Applicant
Tearscience, Inc.

Technical Specification

510(k) Submission ID DEN100017
Product Code ORZ
Medical Specialty / Panel Ophthalmic
Regulation Citation 21 CFR 886.5200
Decision Date 2011-06-28
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) received FDA 510(k) clearance under submission number DEN100017, sponsored by Tearscience, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2011-06-28.

Classification & Regulation

This clearance is catalogued under FDA product code ORZ and 21 CFR 886.5200, within the Ophthalmic review panel as a Class II device.