FDA 510(k)

Sculpt LED腰带（HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C）

K号: K260688 · 2026-05-04

申请人Shenzhen Kaiyan Medical Equipment Co., Ltd.

决定日期2026-05-04

产品代码OLI

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-05-04 under 510(k) number K260688. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)?

Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) is a medical device that received FDA 510(k) clearance on 2026-05-04. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K260688.

When did Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) receive FDA 510(k) clearance?

Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) received FDA 510(k) clearance on 2026-05-04, under 510(k) number K260688.

Who is the listed applicant for Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)?

FDA 510(k)记录将深圳凯研医疗设备有限公司列为申请人。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 Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)?

The FDA product code for Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) is OLI.

列明Shenzhen Kaiyan Medical Equipment Co., Ltd.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。

K253932FACEGYM Pro 设备（HD-109）K254025LED颈部美容面罩（ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H）K260129Lumaflex面板（ZLD-05，ZLD-05A，ZLD-05APro）K253878LUSTRE GoGlow 高级 LED 贴片（PR8001，PR9001）K252603HIGHERDOSE 身体雕塑器（型号：GS-03）K253669TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)

查看所有 24 个设备 →

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。