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FDA 510(k)

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

K-Number: K223507 · 2023-08-04

ApplicantGood Doctors Co., Ltd.
Decision Date2023-08-04
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Good Doctors Co., Ltd.. The 510(k) number is K223507.

When was CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) approved by the FDA?

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

What company makes 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 manufactured by Good Doctors Co., Ltd..

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.

Related Clinical Trials

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Other Devices by Good Doctors Co., Ltd.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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