# DEN230011: OcuCool

- Pathway: De Novo (Direct)
- Applicant: Recensmedical, Inc.
- Decided: Sep 30, 2024 after 592 days
- Product code: QZQ
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for 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.

Source page: https://510kreport.com/device/DEN230011
Methodology: https://510kreport.com/methodology