FDA.reportPublic FDA data

510(k) K243042

Device
Co-Ablation System with Sterile Co-Ablation Probe
Applicant
Hygea Medical Technology Co., Ltd.
510(k) number
K243042
Product code
GEH
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-29
Date received
2024-09-27
Regulation
878.4350
Classification name
Unit, Cryosurgical, Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Xingtong Jiang
Address
Floor 6&7, W. Area Of Bldg. # 8, #30 Yuhua Rd., Shunyi Beijing CN 101318 101318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K252903Verruca-Freeze H PlusCryosurgery, Inc.2025-10-10
K251493Skin Clinic Freeze Point for Warts and Skin TagsCryoconcepts LP2025-05-22
K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP2025-04-15
K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc.2025-03-13
K242288Advanced Cryo Wart RemoverMedical Brands Laboratories B.V.2025-01-21
K243454Verruca-Freeze HCryosurgery, Inc.2024-12-03