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FDA 510(k)

Dr's Light2

K-Number: K173157 · 2018-05-29

Decision Date2018-05-29
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dr's Light2 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 2018-05-29 under 510(k) number K173157. 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 Dr's Light2?

Dr's Light2 is a medical device that received FDA 510(k) clearance on 2018-05-29. The listed applicant is Good Doctors Co., Ltd.. The 510(k) number is K173157.

When did Dr's Light2 receive FDA 510(k) clearance?

Dr's Light2 received FDA 510(k) clearance on 2018-05-29, under 510(k) number K173157.

Who is the listed applicant for Dr's Light2?

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 Dr's Light2?

The FDA product code for Dr's Light2 is EBZ.

Other records listing Good Doctors Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: EBZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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