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FDA 510(k)

健康光微控制器型號 HL-FB（足床）、HL-HB（頭帶）和 HL-FM（面罩）LED 光療系統

K 號：K163079 · 2017-06-13

申請人Healthlight, LLC
決定日期2017-06-13
產品代碼ILY
諮詢委員會PM
決定相當於

器材摘要

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Healthlight, LLC. It received FDA 510(k) clearance on 2017-06-13 under 510(k) number K163079. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System?

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System is a medical device that received FDA 510(k) clearance on 2017-06-13. The listed applicant is Healthlight, LLC. The 510(k) number is K163079.

When did HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System receive FDA 510(k) clearance?

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System received FDA 510(k) clearance on 2017-06-13, under 510(k) number K163079.

Who is the listed applicant for HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System?

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

What is the FDA product code for HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System?

The FDA product code for HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System is ILY.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：ILY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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