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FDA 510(k)

LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)

K-Number: K001746 · 2000-07-19

ApplicantCoherent Star
Decision Date2000-07-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS) is the device name listed in this FDA 510(k) record. The listed applicant is Coherent Star. It received FDA 510(k) clearance on 2000-07-19 under 510(k) number K001746. 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 (FAMILY OF PRODUCTS)?

LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS) is a medical device that received FDA 510(k) clearance on 2000-07-19. The listed applicant is Coherent Star. The 510(k) number is K001746.

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

LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS) received FDA 510(k) clearance on 2000-07-19, under 510(k) number K001746.

Who is the listed applicant for LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)?

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 (FAMILY OF PRODUCTS)?

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

Related Clinical Trials

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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.

K003614LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM

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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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