Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-15 under approval 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. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K200746.

When was IPL Treatment Systems approved by the FDA?

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

What company makes IPL Treatment Systems?

IPL Treatment Systems is manufactured by Shanghai Apolo Medical Technology Co., Ltd..

What is the FDA product code for IPL Treatment Systems?

The FDA product code for IPL Treatment Systems is ONF.

Related Clinical Trials

Related PubMed Literature

Other Devices by Shanghai Apolo Medical Technology Co., Ltd.

View all 14 devices →

Related Devices (Code: ONF)

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.