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510(k) Data Aggregation
K Number
DEN230011Device Name
OcuCool
Manufacturer
Date Cleared
2024-09-30
(592 days)
Regulation Number
N/AWhy did this record match?
Product Code :
QZQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OcuCool is a cooling anesthesia device intended for topical application to the conjunctiva and sclera. OcuCool is intended for the temporary reduction of pain associated with intravitreal injections.
OcuCool is indicated for patients who are allergic to deep penetrating pharmaceutical based anesthetics used for temporarily reducing pain during and following intravitreal injections.
Device Description
The OcuCool is a hand-held, cooling anesthesia device that provides rapid and controlled cooling to the conjunctiva and sclera. It is intended to provide an anesthetic effect via a controlled cooling treatment. The main device performs controlled thermoelectric cooling of a single-use sterile OcuCool Tip. The hand-held device has a rechargeable battery, an LCD display screen to show device status, and two LED indicators to show cooling status and battery charging status. Other features of the hand-held device include the Priming Button, which activates the cooling process in preparation for device use and the Cooling Trigger, which activates the cooling anesthesia process. The device has a built-in 30 second timer and alarm to indicate the effective duration of the anesthetic effect after device use.
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