FDA 510(k)

LYMA 激光

K 號：K210823 · 2022-03-18

決定日期2022-03-18

產品代碼OHS

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

LYMA Laser is the device name listed in this FDA 510(k) record. The listed applicant is Lyma Life , Ltd.. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K210823. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LYMA Laser?

LYMA Laser is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Lyma Life , Ltd.. The 510(k) number is K210823.

When did LYMA Laser receive FDA 510(k) clearance?

LYMA Laser received FDA 510(k) clearance on 2022-03-18, under 510(k) number K210823.

Who is the listed applicant for LYMA Laser?

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

What is the FDA product code for LYMA Laser?

The FDA product code for LYMA Laser is OHS.

其他以 Lyma Life , Ltd. 為申請人之記錄

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K243330LYMA 激光 PRO

相關器械（代碼：OHS）

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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