FDA 510(k)

AYON 身體雕塑系統 (AYON SYSTEM)

K 號：K244050 · 2025-05-12

決定日期2025-05-12

產品代碼QPB

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

AYON Body Contouring System (AYON SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Apyx Medical Corporation. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K244050. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AYON Body Contouring System (AYON SYSTEM)?

AYON Body Contouring System (AYON SYSTEM) is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is Apyx Medical Corporation. The 510(k) number is K244050.

When did AYON Body Contouring System (AYON SYSTEM) receive FDA 510(k) clearance?

AYON Body Contouring System (AYON SYSTEM) received FDA 510(k) clearance on 2025-05-12, under 510(k) number K244050.

Who is the listed applicant for AYON Body Contouring System (AYON SYSTEM)?

FDA 510(k) 記錄中列出 Apyx Medical Corporation 為申請人。這並不單獨確立設備製造商。

What is the FDA product code for AYON Body Contouring System (AYON SYSTEM)?

The FDA product code for AYON Body Contouring System (AYON SYSTEM) is QPB.

其他以 Apyx Medical Corporation 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。

K261710AYON™ Power Liposuction Cannulas 和 AYON™ Power Liposuction Cannula Adaptors K253396AYON 身體雕塑系統™ (AYON SYSTEM)K230586Renuvion® 微型手持器 K230272Renuvion® APR 手柄 K223262Renuvion® APR 手柄 K221830Apyx One Console

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相關器械（代碼：QPB）

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。

K254135脂脂手術藝術家NOUVAG AG K261710AYON™ Power Liposuction Cannulas 和 AYON™ Power Liposuction Cannula AdaptorsApyx Medical Corporation K251944Lipocosm 和諧系統Lipocosm, LLC K253396AYON 身體雕塑系統™ (AYON SYSTEM)Apyx Medical Corporation K252495LSSA (NP-200)Newpong Co., Ltd.K244026PAL 7020 控制台Microaire Surgical Instruments, LLC

官方來源

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