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U.S. Department of Health and Human Services

Product Classification

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Device ocular pattern recorder
Definition A diurnal pattern recorder system is a non-implantable, prescription device incorporating a telemetric sensor intended to detect changes in ocular dimension for monitoring diurnal patterns of IOP fluctuation.
Physical State hydrophillic lens with active strain gauge. RF receiving antenna connected to a recorder to track data over time. unit also includes dedicated software package to review recorded device
Technical Method The device is comprise of a hydrophilic, single use soft contact lens with a sensor and antenna embedded in it, allowing for continuous wireless recording of changes in ocular dimension. An external adhesive antenna worn around the eye is used to send power to, and receive measurement data, from the embedded system. The external adhesive antenna is connected to a pocket-size recorder worn by the patient during the recording session for up to 24 hours. At the end of the session, the data is transferred from the recorder to the computer of the healthcare professional for review using a dedicated software.
Target Area cornea of the eye
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodePLZ
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.1925
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible