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FDA 510(k)

Dermatological Diode Laser Systems

K-Number: K202257 · 2021-04-23

ApplicantZhuolu Jontelaser Manufacturing Technology Co., Ltd.
Decision Date2021-04-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dermatological Diode 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 2021-04-23 under 510(k) number K202257. 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 Diode Laser Systems?

Dermatological Diode Laser Systems is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Zhuolu Jontelaser Manufacturing Technology Co., Ltd.. The 510(k) number is K202257.

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

Dermatological Diode Laser Systems received FDA 510(k) clearance on 2021-04-23, under 510(k) number K202257.

Who is the listed applicant for Dermatological Diode 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 Diode Laser Systems?

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

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.

K202250Dermatological Carbon Dioxide 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.

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Official Source

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