FDA 510(k)

StarFormer (M008-3T)

K号: K241785 · 2025-03-27

决定日期2025-03-27

产品代码QPL

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决定实质等同

器械摘要

StarFormer (M008-3T) is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.O.O.. It received FDA 510(k) clearance on 2025-03-27 under 510(k) number K241785. The device is classified under product code QPL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the StarFormer (M008-3T)?

StarFormer (M008-3T) is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is Fotona D.O.O.. The 510(k) number is K241785.

When did StarFormer (M008-3T) receive FDA 510(k) clearance?

StarFormer (M008-3T) received FDA 510(k) clearance on 2025-03-27, under 510(k) number K241785.

Who is the listed applicant for StarFormer (M008-3T)?

FDA 510(k)记录显示Fotona D.O.O.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for StarFormer (M008-3T)?

The FDA product code for StarFormer (M008-3T) is QPL.

列明Fotona D.O.O.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。

K252723Dynamis Pro Family K242202LightWalker激光系统家族 K234061StarFormer K221274StarFormer，TightWave K223540AvalancheLase家庭 K221712Fotona XPulse 激光系统家族 (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)

查看所有 17 个设备 →

官方来源

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