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FDA 510(k)

IPL Treatment Systems

K-Number: K200746 · 2020-05-15

Decision Date2020-05-15
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Treatment Systems is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-15 under 510(k) number K200746. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPL Treatment Systems?

IPL Treatment Systems is a medical device that received FDA 510(k) clearance on 2020-05-15. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K200746.

When did IPL Treatment Systems receive FDA 510(k) clearance?

IPL Treatment Systems received FDA 510(k) clearance on 2020-05-15, under 510(k) number K200746.

Who is the listed applicant for IPL Treatment Systems?

The FDA 510(k) record lists Shanghai Apolo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL Treatment Systems?

The FDA product code for IPL Treatment Systems is ONF.

Other records listing Shanghai Apolo Medical Technology 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.

View all 14 devices →

Related Devices (Code: ONF)

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.