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FDA 510(k)

TargetCool™ (RM-DT02W)

K-Number: K253114 · 2025-10-16

ApplicantRecensmedical, Inc.
Decision Date2025-10-16
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TargetCool™ (RM-DT02W) is a medical device manufactured by Recensmedical, Inc.. It received FDA 510(k) clearance on 2025-10-16 under approval number K253114. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TargetCool™ (RM-DT02W)?

TargetCool™ (RM-DT02W) is a medical device that received FDA 510(k) clearance on 2025-10-16. It is manufactured by Recensmedical, Inc.. The 510(k) number is K253114.

When was TargetCool™ (RM-DT02W) approved by the FDA?

TargetCool™ (RM-DT02W) received FDA 510(k) clearance on 2025-10-16, under approval number K253114.

What company makes TargetCool™ (RM-DT02W)?

TargetCool™ (RM-DT02W) is manufactured by Recensmedical, Inc..

What is the FDA product code for TargetCool™ (RM-DT02W)?

The FDA product code for TargetCool™ (RM-DT02W) is GEH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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