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FDA 510(k)

MODEL 305AA PORTABLE LASER

K-Number: K841781 · 1984-11-07

ApplicantLaser Spectrum, Inc.
Decision Date1984-11-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 305AA PORTABLE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Laser Spectrum, Inc.. It received FDA 510(k) clearance on 1984-11-07 under 510(k) number K841781. 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 MODEL 305AA PORTABLE LASER?

MODEL 305AA PORTABLE LASER is a medical device that received FDA 510(k) clearance on 1984-11-07. The listed applicant is Laser Spectrum, Inc.. The 510(k) number is K841781.

When did MODEL 305AA PORTABLE LASER receive FDA 510(k) clearance?

MODEL 305AA PORTABLE LASER received FDA 510(k) clearance on 1984-11-07, under 510(k) number K841781.

Who is the listed applicant for MODEL 305AA PORTABLE LASER?

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

What is the FDA product code for MODEL 305AA PORTABLE LASER?

The FDA product code for MODEL 305AA PORTABLE LASER is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Laser Spectrum, 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.

K863520CO2 LASER MICROMANIPULATORK844765ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMENK842498DANIELL DBL PUNCTURE LASER LAPAROSCOPYK841668CO2 LAPAROSCOPE

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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