AYON 身体塑形系统 (AYON SYSTEM)
K号: K244050 · 2025-05-12
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决定日期2025-05-12
产品代码QPB
咨询委员会SU
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器械摘要
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.
常见问题
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)记录列出了Apyx Medical Corporation为申请人。这本身并不足以确立该设备制造商的身份。
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Apyx Medical Corporation为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：QPB）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K254135脂塑术艺术家NOUVAG AGK261710AYON™ Power Liposuction Cannulas和AYON™ Power Liposuction Cannula AdaptorsApyx Medical CorporationK251944Lipocosm谐波系统Lipocosm, LLCK253396AYON 身体塑形系统® (AYON SYSTEM)Apyx Medical CorporationK252495LSSA (NP-200)Newpong Co., Ltd.K244026PAL 7020控制台Microaire Surgical Instruments, LLC
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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