Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TargetCool

K-Number: K220674 · 2022-03-31

ApplicantRecensmedical, Inc.
Decision Date2022-03-31
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TargetCool is a medical device manufactured by Recensmedical, Inc.. It received FDA 510(k) clearance on 2022-03-31 under approval number K220674. 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?

TargetCool is a medical device that received FDA 510(k) clearance on 2022-03-31. It is manufactured by Recensmedical, Inc.. The 510(k) number is K220674.

When was TargetCool approved by the FDA?

TargetCool received FDA 510(k) clearance on 2022-03-31, under approval number K220674.

What company makes TargetCool?

TargetCool is manufactured by Recensmedical, Inc..

What is the FDA product code for TargetCool?

The FDA product code for TargetCool is GEH.

Other Devices by Recensmedical, Inc.

K203481CryoVIVE K221234TargetCool K230599TargetCool™ DEN230011OcuCool K253114TargetCool™ (RM-DT02W) K253348TargetCool-e

View all 7 devices →

Related Devices (Code: GEH)

K162695truFreeze SystemCSA Medical, Inc. K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd. K161480R2 Dermal Cooling SystemR2 Dermatology K161294Compound W Wart Removal System Dual PowerMedtech Products, Inc. K161615AccurettH&O Equipments, Nv/Sa K161557truFreeze SystemCSA Medical, Inc.

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.

↑