TargetCool-e

FDA 510(k) K253348 · Recensmedical, Inc.

Substantially Equivalent

510(k) numberK253348

Submission

Device name
TargetCool-e
Applicant
Recensmedical, Inc.
Hwaseong-Si, KR
Received
September 30, 2025
Decision date
October 15, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GEH – Unit, Cryosurgical, Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4350
Specialty
General, Plastic Surgery

Other 510(k)s with product code GEH

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K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)GEH · Traditional Serpex Medical09/02/2026SE
K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)GEH · Traditional Serpex Medical06/30/2026SE
K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesGEH · Special Erbe Elektromedizin GmbH06/09/2026SE
K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…GEH · Traditional Erbe Elektromedizin GmbH04/22/2026SE
K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)GEH · Traditional Medical Brands Laboratories B.V.04/02/2026SE
K260377XSense Cryoablation System with CryoProbesGEH · Special IceCure Medical , Ltd.02/24/2026SE
K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…GEH · Traditional Medinice S.A.02/13/2026SE
K251524Dr. Yglo Skin Tag RemoverGEH · Traditional Theotclab Healthcare B.V.01/12/2026SE
K250742Focused Cryotherapy SystemGEH · Traditional Focused Cryo, Inc.12/09/2025SE
K253114TargetCool™ (RM-DT02W)GEH · Special Recensmedical, Inc.10/16/2025SE

More from Recensmedical, Inc.

510(k)DeviceDecision
K253114TargetCool™ (RM-DT02W)GEH · Special 10/16/2025SE
K230599TargetCool™GEH · Traditional 06/22/2023SE
K221234TargetCoolGEH · Traditional 07/22/2022SE
K220674TargetCoolGEH · Special 03/31/2022SE
K203481CryoVIVEGEH · Traditional 05/13/2021SE

Questions and answers

When was TargetCool-e cleared by the FDA?

TargetCool-e (K253348) received a 510(k) decision of Substantially Equivalent on October 15, 2025, 15 days after the submission was received.

What is the product code of K253348?

The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.