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FDA 510(k)

PETERIO UNIVERSAL LASER SCANNING HANDPIECE

K-Number: K073048 · 2008-02-28

ApplicantScilex, Ltd.
Decision Date2008-02-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PETERIO UNIVERSAL LASER SCANNING HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Scilex, Ltd.. It received FDA 510(k) clearance on 2008-02-28 under 510(k) number K073048. 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 PETERIO UNIVERSAL LASER SCANNING HANDPIECE?

PETERIO UNIVERSAL LASER SCANNING HANDPIECE is a medical device that received FDA 510(k) clearance on 2008-02-28. The listed applicant is Scilex, Ltd.. The 510(k) number is K073048.

When did PETERIO UNIVERSAL LASER SCANNING HANDPIECE receive FDA 510(k) clearance?

PETERIO UNIVERSAL LASER SCANNING HANDPIECE received FDA 510(k) clearance on 2008-02-28, under 510(k) number K073048.

Who is the listed applicant for PETERIO UNIVERSAL LASER SCANNING HANDPIECE?

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

What is the FDA product code for PETERIO UNIVERSAL LASER SCANNING HANDPIECE?

The FDA product code for PETERIO UNIVERSAL LASER SCANNING HANDPIECE is GEX. This falls under the Gastroenterology category.

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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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