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FDA 510(k)

TargetCool-e

K-Number: K253348 · 2025-10-15

ApplicantRecensmedical, Inc.
Decision Date2025-10-15
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TargetCool-e is a medical device manufactured by Recensmedical, Inc.. It received FDA 510(k) clearance on 2025-10-15 under approval number K253348. 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-e?

TargetCool-e is a medical device that received FDA 510(k) clearance on 2025-10-15. It is manufactured by Recensmedical, Inc.. The 510(k) number is K253348.

When was TargetCool-e approved by the FDA?

TargetCool-e received FDA 510(k) clearance on 2025-10-15, under approval number K253348.

What company makes TargetCool-e?

TargetCool-e is manufactured by Recensmedical, Inc..

What is the FDA product code for TargetCool-e?

The FDA product code for TargetCool-e is GEH.

Other Devices by Recensmedical, Inc.

K203481CryoVIVE K221234TargetCool K220674TargetCool K230599TargetCool™ DEN230011OcuCool K253114TargetCool™ (RM-DT02W)

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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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