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FDA 510(k)

LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS

K-Number: K030527 · 2003-05-20

ApplicantLumenis
Decision Date2003-05-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis. It received FDA 510(k) clearance on 2003-05-20 under 510(k) number K030527. 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 LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS?

LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS is a medical device that received FDA 510(k) clearance on 2003-05-20. The listed applicant is Lumenis. The 510(k) number is K030527.

When did LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS receive FDA 510(k) clearance?

LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS received FDA 510(k) clearance on 2003-05-20, under 510(k) number K030527.

Who is the listed applicant for LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS?

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

What is the FDA product code for LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS?

The FDA product code for LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS is GEX. This falls under the Gastroenterology category.

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Other records listing Lumenis 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.

K100415ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEMK020591BCLEARK011197DERMACLEAR UV-B PHOTOTHERAPY SYSTEMK011703LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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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