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FDA 510(k)

LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG.

K-Number: K901128 · 1990-06-05

ApplicantLasercomp
Decision Date1990-06-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG. is the device name listed in this FDA 510(k) record. The listed applicant is Lasercomp. It received FDA 510(k) clearance on 1990-06-05 under 510(k) number K901128. 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 STAR 10 FOR ORAL,GYNECOLOGY SURG.?

LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG. is a medical device that received FDA 510(k) clearance on 1990-06-05. The listed applicant is Lasercomp. The 510(k) number is K901128.

When did LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG. receive FDA 510(k) clearance?

LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG. received FDA 510(k) clearance on 1990-06-05, under 510(k) number K901128.

Who is the listed applicant for LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG.?

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

What is the FDA product code for LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG.?

The FDA product code for LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG. 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 Lasercomp 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.

K901127LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY

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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