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FDA 510(k)

Fotona XPulse Pro Laser Platform

K-Number: K202991 · 2021-06-22

ApplicantFotona D.O.O.
Decision Date2021-06-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Fotona XPulse Pro Laser Platform is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.O.O.. It received FDA 510(k) clearance on 2021-06-22 under 510(k) number K202991. 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 Fotona XPulse Pro Laser Platform?

Fotona XPulse Pro Laser Platform is a medical device that received FDA 510(k) clearance on 2021-06-22. The listed applicant is Fotona D.O.O.. The 510(k) number is K202991.

When did Fotona XPulse Pro Laser Platform receive FDA 510(k) clearance?

Fotona XPulse Pro Laser Platform received FDA 510(k) clearance on 2021-06-22, under 510(k) number K202991.

Who is the listed applicant for Fotona XPulse Pro Laser Platform?

The FDA 510(k) record lists Fotona D.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fotona XPulse Pro Laser Platform?

The FDA product code for Fotona XPulse Pro Laser Platform is GEX. This falls under the Gastroenterology category.

Other records listing Fotona D.O.O. 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.

K241785StarFormer (M008-3T)K242202LightWalker Laser System FamilyK234061StarFormerK221274StarFormer, TightWaveK223540AvalancheLase FamilyK221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)

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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

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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