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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 the device name listed in this FDA 510(k) record. The listed applicant is Zhuolu Jontelaser Manufacturing Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) 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. The listed applicant is Zhuolu Jontelaser Manufacturing Technology Co., Ltd.. The 510(k) number is K202250.

When did Dermatological Carbon Dioxide Laser Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for Dermatological Carbon Dioxide Laser Systems?

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

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.

Related Clinical Trials

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.

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Other records listing Zhuolu Jontelaser Manufacturing 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.

K202257Dermatological Diode Laser Systems

Related Devices (Code: GEX)

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.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

Official Source

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