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FDA 510(k)

OPTICA 60 ND;YAG SURGICAL LASER SYSTEM

K-Number: K912703 · 1991-10-11

ApplicantXintec Corporation
Decision Date1991-10-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTICA 60 ND;YAG SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xintec Corporation. It received FDA 510(k) clearance on 1991-10-11 under 510(k) number K912703. 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 OPTICA 60 ND;YAG SURGICAL LASER SYSTEM?

OPTICA 60 ND;YAG SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Xintec Corporation. The 510(k) number is K912703.

When did OPTICA 60 ND;YAG SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

OPTICA 60 ND;YAG SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1991-10-11, under 510(k) number K912703.

Who is the listed applicant for OPTICA 60 ND;YAG SURGICAL LASER SYSTEM?

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

What is the FDA product code for OPTICA 60 ND;YAG SURGICAL LASER SYSTEM?

The FDA product code for OPTICA 60 ND;YAG SURGICAL LASER SYSTEM 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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