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FDA 510(k)

STARLIGHT PULSED DIODE ARRAY LASER SYSTEM

K-Number: K973324 · 1997-12-03

ApplicantStar Medical Technologies, Inc.
Decision Date1997-12-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STARLIGHT PULSED DIODE ARRAY LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Star Medical Technologies, Inc.. It received FDA 510(k) clearance on 1997-12-03 under 510(k) number K973324. 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 STARLIGHT PULSED DIODE ARRAY LASER SYSTEM?

STARLIGHT PULSED DIODE ARRAY LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-03. The listed applicant is Star Medical Technologies, Inc.. The 510(k) number is K973324.

When did STARLIGHT PULSED DIODE ARRAY LASER SYSTEM receive FDA 510(k) clearance?

STARLIGHT PULSED DIODE ARRAY LASER SYSTEM received FDA 510(k) clearance on 1997-12-03, under 510(k) number K973324.

Who is the listed applicant for STARLIGHT PULSED DIODE ARRAY LASER SYSTEM?

The FDA 510(k) record lists Star Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STARLIGHT PULSED DIODE ARRAY LASER SYSTEM?

The FDA product code for STARLIGHT PULSED DIODE ARRAY LASER SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Star Medical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K982940LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEMK974346STARLIGHT PULSED DIODE ARRAY LASER SYSTEM

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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