OcuCool

K Number: DEN230011 · Decision Sep 30, 2024

Classifications

FEI Numbers

Registration Numbers

Same Product Code

Applicant Total

Review Days

592

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K Number	Device Name	Decision Date	Decision
K253114	TargetCool (RM-DT02W)	Oct 16, 2025	Substantially Equivalent
K253348	TargetCool-e	Oct 15, 2025	Substantially Equivalent
K230599	TargetCool	Jun 22, 2023	Substantially Equivalent
K221234	TargetCool	Jul 22, 2022	Substantially Equivalent
K220674	TargetCool	Mar 31, 2022	Substantially Equivalent
K203481	CryoVIVE	May 13, 2021	Substantially Equivalent

Address: #507, #908, Sk V1 Center, 830 Dongtansunhwan-Daero, Hwaseong-Si, 18468, South Korea
Contact: Gun-Ho Kim

This FDA 510(k) entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

This FDA 510(k) entry is associated with 1 registration number. Click on an entry to view related FDA registrations.

FDA 510(k) Clearances

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Applicant

Recensmedical, Inc.

Product Code

View the full FDA classification for product code QZQ.

PSUR Report

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