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FDA 510(k)

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories

K-Number: K203544 · 2020-12-24

ApplicantLumenis, Ltd.
Decision Date2020-12-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2020-12-24 under 510(k) number K203544. 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 UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories?

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2020-12-24. The listed applicant is Lumenis, Ltd.. The 510(k) number is K203544.

When did UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories receive FDA 510(k) clearance?

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories received FDA 510(k) clearance on 2020-12-24, under 510(k) number K203544.

Who is the listed applicant for UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories?

The FDA 510(k) record lists Lumenis, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories?

The FDA product code for UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.

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Other records listing Lumenis, 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.

K211979Lumenis Y&R Laser SystemK212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesK202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesK201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesK193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemK180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO

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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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