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FDA 510(k)

PULSTAR

K-Number: K992061 · 1999-07-30

ApplicantLasermed, Inc.
Decision Date1999-07-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PULSTAR is the device name listed in this FDA 510(k) record. The listed applicant is Lasermed, Inc.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K992061. 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 PULSTAR?

PULSTAR is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Lasermed, Inc.. The 510(k) number is K992061.

When did PULSTAR receive FDA 510(k) clearance?

PULSTAR received FDA 510(k) clearance on 1999-07-30, under 510(k) number K992061.

Who is the listed applicant for PULSTAR?

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

What is the FDA product code for PULSTAR?

The FDA product code for PULSTAR is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Lasermed, 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.

K970637ACCUCURE 1000K964486ACCUCURE 3000

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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