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FDA 510(k)

DA VINCI FEMTOSECOND SURGICAL LASER

K-Number: K053511 · 2006-03-10

ApplicantSie Ltd Surgical Instrument Engineering
Decision Date2006-03-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DA VINCI FEMTOSECOND SURGICAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Sie Ltd Surgical Instrument Engineering. It received FDA 510(k) clearance on 2006-03-10 under 510(k) number K053511. 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 DA VINCI FEMTOSECOND SURGICAL LASER?

DA VINCI FEMTOSECOND SURGICAL LASER is a medical device that received FDA 510(k) clearance on 2006-03-10. The listed applicant is Sie Ltd Surgical Instrument Engineering. The 510(k) number is K053511.

When did DA VINCI FEMTOSECOND SURGICAL LASER receive FDA 510(k) clearance?

DA VINCI FEMTOSECOND SURGICAL LASER received FDA 510(k) clearance on 2006-03-10, under 510(k) number K053511.

Who is the listed applicant for DA VINCI FEMTOSECOND SURGICAL LASER?

The FDA 510(k) record lists Sie Ltd Surgical Instrument Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DA VINCI FEMTOSECOND SURGICAL LASER?

The FDA product code for DA VINCI FEMTOSECOND SURGICAL LASER 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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