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FDA 510(k)

Intense Pulsed Light Treatment System

K-Number: K192521 · 2019-12-06

ApplicantShangdong Huamei Technology Co., Ltd.
Decision Date2019-12-06
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulsed Light Treatment System is a medical device manufactured by Shangdong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-06 under approval number K192521. 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 Intense Pulsed Light Treatment System?

Intense Pulsed Light Treatment System is a medical device that received FDA 510(k) clearance on 2019-12-06. It is manufactured by Shangdong Huamei Technology Co., Ltd.. The 510(k) number is K192521.

When was Intense Pulsed Light Treatment System approved by the FDA?

Intense Pulsed Light Treatment System received FDA 510(k) clearance on 2019-12-06, under approval number K192521.

What company makes Intense Pulsed Light Treatment System?

Intense Pulsed Light Treatment System is manufactured by Shangdong Huamei Technology Co., Ltd..

What is the FDA product code for Intense Pulsed Light Treatment System?

The FDA product code for Intense Pulsed Light Treatment System is ONF.

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Other Devices by Shangdong Huamei Technology Co., Ltd.

K192528CO2 Laser Therapy System K202758Nd: YAG Laser Therapy Systems HM-YL900 K200751Photodynamic Therapy (PDT) Equipment K230816Intense Pulsed Light Treatment System

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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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