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FDA 510(k)

USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM

K-Number: K943638 · 1995-03-06

ApplicantUnited States Dental Laser, Inc.
Decision Date1995-03-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is United States Dental Laser, Inc.. It received FDA 510(k) clearance on 1995-03-06 under 510(k) number K943638. 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 USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM?

USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is United States Dental Laser, Inc.. The 510(k) number is K943638.

When did USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM receive FDA 510(k) clearance?

USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM received FDA 510(k) clearance on 1995-03-06, under 510(k) number K943638.

Who is the listed applicant for USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM?

The FDA 510(k) record lists United States Dental Laser, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM?

The FDA product code for USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Related Devices (Code: GEX)

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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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