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FDA 510(k)

Intense Pulsed Light System

K-Number: K231394 · 2023-08-09

ApplicantSmedtrum Medical Technology Co., Ltd.
Decision Date2023-08-09
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulsed Light System is a medical device manufactured by Smedtrum Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-09 under approval number K231394. 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 System?

Intense Pulsed Light System is a medical device that received FDA 510(k) clearance on 2023-08-09. It is manufactured by Smedtrum Medical Technology Co., Ltd.. The 510(k) number is K231394.

When was Intense Pulsed Light System approved by the FDA?

Intense Pulsed Light System received FDA 510(k) clearance on 2023-08-09, under approval number K231394.

What company makes Intense Pulsed Light System?

Intense Pulsed Light System is manufactured by Smedtrum Medical Technology Co., Ltd..

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

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

Related Clinical Trials

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Other Devices by Smedtrum Medical Technology Co., Ltd.

K221597CO2 Laser System K230580Diode Laser System K240482Intense Pulsed Light System (ST-690) K240118Picosecond Nd:YAG Laser System

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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.

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