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FDA 510(k)

SOLIUS PRO UVB灯面板

K号: K252960 · 2026-01-16

决定日期2026-01-16
产品代码SGZ
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

SOLIUS PRO UVB Light Panel is the device name listed in this FDA 510(k) record. The listed applicant is Solius Labs, Inc.. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K252960. The device is classified under product code SGZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SOLIUS PRO UVB Light Panel?

SOLIUS PRO UVB Light Panel is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Solius Labs, Inc.. The 510(k) number is K252960.

When did SOLIUS PRO UVB Light Panel receive FDA 510(k) clearance?

SOLIUS PRO UVB Light Panel received FDA 510(k) clearance on 2026-01-16, under 510(k) number K252960.

Who is the listed applicant for SOLIUS PRO UVB Light Panel?

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

What is the FDA product code for SOLIUS PRO UVB Light Panel?

The FDA product code for SOLIUS PRO UVB Light Panel is SGZ.

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