FDA 510(k)

Ulthera系统（UC-1控制单元PRIME型号2.1）

K号: K250418 · 2025-05-13

决定日期2025-05-13

产品代码OHV

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决定实质等同

器械摘要

Ulthera System (UC-1 Control Unit PRIME Model 2.1) is the device name listed in this FDA 510(k) record. The listed applicant is Ulthera, Inc.. It received FDA 510(k) clearance on 2025-05-13 under 510(k) number K250418. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ulthera System (UC-1 Control Unit PRIME Model 2.1)?

Ulthera System (UC-1 Control Unit PRIME Model 2.1) is a medical device that received FDA 510(k) clearance on 2025-05-13. The listed applicant is Ulthera, Inc.. The 510(k) number is K250418.

When did Ulthera System (UC-1 Control Unit PRIME Model 2.1) receive FDA 510(k) clearance?

Ulthera System (UC-1 Control Unit PRIME Model 2.1) received FDA 510(k) clearance on 2025-05-13, under 510(k) number K250418.

Who is the listed applicant for Ulthera System (UC-1 Control Unit PRIME Model 2.1)?

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

What is the FDA product code for Ulthera System (UC-1 Control Unit PRIME Model 2.1)?

The FDA product code for Ulthera System (UC-1 Control Unit PRIME Model 2.1) is OHV.

列明Ulthera, Inc.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。

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官方来源

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