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)

CryoTouch

K-Number: K183601 · 2019-04-18

ApplicantCryoconcepts LP
Decision Date2019-04-18
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CryoTouch is a medical device manufactured by Cryoconcepts LP. It received FDA 510(k) clearance on 2019-04-18 under approval number K183601. 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 CryoTouch?

CryoTouch is a medical device that received FDA 510(k) clearance on 2019-04-18. It is manufactured by Cryoconcepts LP. The 510(k) number is K183601.

When was CryoTouch approved by the FDA?

CryoTouch received FDA 510(k) clearance on 2019-04-18, under approval number K183601.

What company makes CryoTouch?

CryoTouch is manufactured by Cryoconcepts LP.

What is the FDA product code for CryoTouch?

The FDA product code for CryoTouch is GEH.

Other Devices by Cryoconcepts LP

K172769CryOmega Flexx K190407CryoLab K211099Freeze’n Clear Skin Clinic Warts & Tags K242625Freeze Point & Private Label Versions K240106Histofreezer V K251493Skin Clinic Freeze Point for Warts and Skin Tags

View all 8 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.

↑