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FDA 510(k)

Dermatological Carbon Dioxide Laser Systems

K-Number: K202250 · 2020-11-25

ApplicantZhuolu Jontelaser Manufacturing Technology Co., Ltd.
Decision Date2020-11-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dermatological Carbon Dioxide Laser Systems is a medical device manufactured by Zhuolu Jontelaser Manufacturing Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-11-25 under approval number K202250. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dermatological Carbon Dioxide Laser Systems?

Dermatological Carbon Dioxide Laser Systems is a medical device that received FDA 510(k) clearance on 2020-11-25. It is manufactured by Zhuolu Jontelaser Manufacturing Technology Co., Ltd.. The 510(k) number is K202250.

When was Dermatological Carbon Dioxide Laser Systems approved by the FDA?

Dermatological Carbon Dioxide Laser Systems received FDA 510(k) clearance on 2020-11-25, under approval number K202250.

What company makes Dermatological Carbon Dioxide Laser Systems?

Dermatological Carbon Dioxide Laser Systems is manufactured by Zhuolu Jontelaser Manufacturing Technology Co., Ltd..

What is the FDA product code for Dermatological Carbon Dioxide Laser Systems?

The FDA product code for Dermatological Carbon Dioxide Laser Systems is GEX. This falls under the Gastroenterology category.

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Other Devices by Zhuolu Jontelaser Manufacturing Technology Co., Ltd.

K202257Dermatological Diode Laser Systems

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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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