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FDA 510(k)

OPTICA 25 ND:YAG DENTAL LASER SYSTEM

K-Number: K913839 · 1992-03-13

ApplicantXintec Corporation
Decision Date1992-03-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTICA 25 ND:YAG DENTAL 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 1992-03-13 under 510(k) number K913839. 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 25 ND:YAG DENTAL LASER SYSTEM?

OPTICA 25 ND:YAG DENTAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1992-03-13. The listed applicant is Xintec Corporation. The 510(k) number is K913839.

When did OPTICA 25 ND:YAG DENTAL LASER SYSTEM receive FDA 510(k) clearance?

OPTICA 25 ND:YAG DENTAL LASER SYSTEM received FDA 510(k) clearance on 1992-03-13, under 510(k) number K913839.

Who is the listed applicant for OPTICA 25 ND:YAG DENTAL 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 25 ND:YAG DENTAL LASER SYSTEM?

The FDA product code for OPTICA 25 ND:YAG DENTAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Xintec Corporation as applicant

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K082230VECTRA PLUS LASER SYSTEM AND ACCESSORIESK990914POLARIS DIODE LASER SYSTEM AND ACCESSORIESK981627PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)K981350ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIESK971912PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIESK971065DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES

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Related Devices (Code: GEX)

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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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