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FDA 510(k)

LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.

K-Number: K060448 · 2006-07-06

ApplicantLumenis, Ltd.
Decision Date2006-07-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2006-07-06 under 510(k) number K060448. 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 ONE FAMILY OF SYSTEMS; LUMENIS ONE.?

LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. is a medical device that received FDA 510(k) clearance on 2006-07-06. The listed applicant is Lumenis, Ltd.. The 510(k) number is K060448.

When did LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. receive FDA 510(k) clearance?

LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. received FDA 510(k) clearance on 2006-07-06, under 510(k) number K060448.

Who is the listed applicant for LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.?

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 LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.?

The FDA product code for LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. is GEX. This falls under the Gastroenterology category.

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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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