FDA 510(k)

CL-DP40（Dr's Light PRIME），CL-DP40（Dr's Light CHOICE）

K号: K223507 · 2023-08-04

决定日期2023-08-04

产品代码EBZ

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决定实质等同

器械摘要

CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) is the device name listed in this FDA 510(k) record. The listed applicant is Good Doctors Co., Ltd.. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K223507. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)?

CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Good Doctors Co., Ltd.. The 510(k) number is K223507.

When did CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) receive FDA 510(k) clearance?

CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) received FDA 510(k) clearance on 2023-08-04, under 510(k) number K223507.

Who is the listed applicant for CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)?

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

What is the FDA product code for CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)?

The FDA product code for CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) is EBZ.

列明Good Doctors 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。

K183471IC-WHCD100 (Inspire)K173157Dr's Light2 K171867Dr's Finder NEO K151274Dr's Finder

官方来源

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