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FDA 510(k)

LASERCOMP MODEL: 10 STAR 10

K-Number: K885170 · 1989-06-05

ApplicantLaser-West
Decision Date1989-06-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERCOMP MODEL: 10 STAR 10 is the device name listed in this FDA 510(k) record. The listed applicant is Laser-West. It received FDA 510(k) clearance on 1989-06-05 under 510(k) number K885170. 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 LASERCOMP MODEL: 10 STAR 10?

LASERCOMP MODEL: 10 STAR 10 is a medical device that received FDA 510(k) clearance on 1989-06-05. The listed applicant is Laser-West. The 510(k) number is K885170.

When did LASERCOMP MODEL: 10 STAR 10 receive FDA 510(k) clearance?

LASERCOMP MODEL: 10 STAR 10 received FDA 510(k) clearance on 1989-06-05, under 510(k) number K885170.

Who is the listed applicant for LASERCOMP MODEL: 10 STAR 10?

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

What is the FDA product code for LASERCOMP MODEL: 10 STAR 10?

The FDA product code for LASERCOMP MODEL: 10 STAR 10 is GEX. This falls under the Gastroenterology category.

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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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