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FDA 510(k)

LUMENIS SELECTA DUET

K-Number: K021550 · 2002-08-09

ApplicantEllex Medical Pty, Ltd.
Decision Date2002-08-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUMENIS SELECTA DUET is the device name listed in this FDA 510(k) record. The listed applicant is Ellex Medical Pty, Ltd.. It received FDA 510(k) clearance on 2002-08-09 under 510(k) number K021550. 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 SELECTA DUET?

LUMENIS SELECTA DUET is a medical device that received FDA 510(k) clearance on 2002-08-09. The listed applicant is Ellex Medical Pty, Ltd.. The 510(k) number is K021550.

When did LUMENIS SELECTA DUET receive FDA 510(k) clearance?

LUMENIS SELECTA DUET received FDA 510(k) clearance on 2002-08-09, under 510(k) number K021550.

Who is the listed applicant for LUMENIS SELECTA DUET?

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

What is the FDA product code for LUMENIS SELECTA DUET?

The FDA product code for LUMENIS SELECTA DUET is GEX. This falls under the Gastroenterology category.

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Other records listing Ellex Medical Pty, Ltd. as applicant

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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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