FDA 510(k)

LYMA 激光 PRO

K 號：K243330 · 2025-02-21

決定日期2025-02-21

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 PRO 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 2025-02-21 under 510(k) number K243330. 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 PRO?

LYMA Laser PRO is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Lyma Life , Ltd.. The 510(k) number is K243330.

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

LYMA Laser PRO received FDA 510(k) clearance on 2025-02-21, under 510(k) number K243330.

Who is the listed applicant for LYMA Laser PRO?

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 PRO?

The FDA product code for LYMA Laser PRO is OHS.

其他以 Lyma Life , Ltd. 為申請人之記錄

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K210823LYMA 激光

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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