FDA 510(k)

Freeze'n Clear皮膚診所疣子與標籤

K 號：K211099 · 2022-06-17

決定日期2022-06-17

產品代碼GEH

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Freeze’n Clear Skin Clinic Warts & Tags is the device name listed in this FDA 510(k) record. The listed applicant is Cryoconcepts LP. It received FDA 510(k) clearance on 2022-06-17 under 510(k) number K211099. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Freeze’n Clear Skin Clinic Warts & Tags?

Freeze’n Clear Skin Clinic Warts & Tags is a medical device that received FDA 510(k) clearance on 2022-06-17. The listed applicant is Cryoconcepts LP. The 510(k) number is K211099.

When did Freeze’n Clear Skin Clinic Warts & Tags receive FDA 510(k) clearance?

Freeze’n Clear Skin Clinic Warts & Tags received FDA 510(k) clearance on 2022-06-17, under 510(k) number K211099.

Who is the listed applicant for Freeze’n Clear Skin Clinic Warts & Tags?

The FDA 510(k) record lists Cryoconcepts LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Freeze’n Clear Skin Clinic Warts & Tags?

The FDA product code for Freeze’n Clear Skin Clinic Warts & Tags is GEH.

其他以 Cryoconcepts LP 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：GEH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262420Maverix 冷凍切片儀 Pro (MCB Pro) (MCBP-1000)；Maverix 冷凍針筒 (CC-1000)Serpex Medical K261068Maverix冷凍切片探針（MCB1000）；Maverix冷凍針筒（CC1000）Serpex Medical K261806ERBECRYO 2 冷凍外科儀器及附件Erbe Elektromedizin GmbH K253230ERBECRYO 2 冷凍外科儀器及附件：ERBECRYO 2 冷凍外科儀器；Erbe 柔性冷凍針Erbe Elektromedizin GmbH K252198Advanced 冷冻皮肤疣去除器（Advanced 皮肤疣去除器）Medical Brands Laboratories B.V.K260377XSense冷凍消融系統搭配冷凍探針IceCure Medical , Ltd.

官方來源

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