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FDA 510(k)

LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM

K-Number: K003614 · 2001-03-13

ApplicantCoherent Star
Decision Date2001-03-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coherent Star. It received FDA 510(k) clearance on 2001-03-13 under 510(k) number K003614. 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 LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM?

LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-13. The listed applicant is Coherent Star. The 510(k) number is K003614.

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

LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM received FDA 510(k) clearance on 2001-03-13, under 510(k) number K003614.

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

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

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

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

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Other records listing Coherent Star 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.

K001746LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)

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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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