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FDA 510(k)

MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33

K-Number: K901638 · 1990-06-27

ApplicantLasermatic, Inc.
Decision Date1990-06-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 is the device name listed in this FDA 510(k) record. The listed applicant is Lasermatic, Inc.. It received FDA 510(k) clearance on 1990-06-27 under 510(k) number K901638. 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 MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33?

MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 is a medical device that received FDA 510(k) clearance on 1990-06-27. The listed applicant is Lasermatic, Inc.. The 510(k) number is K901638.

When did MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 receive FDA 510(k) clearance?

MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 received FDA 510(k) clearance on 1990-06-27, under 510(k) number K901638.

Who is the listed applicant for MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33?

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

What is the FDA product code for MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33?

The FDA product code for MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 is GEX. This falls under the Gastroenterology category.

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Other records listing Lasermatic, 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.

K903131LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEMK893529COMBOLASER MODEL 5050K871875MODEL 5050 SURGILASER FOR OB-GYN USEK871934MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USEK871932MODEL 5050 SURGILASER FOR UROLOGY USEK871876MODEL 5050 SURGILASER FOR PULMONARY USE

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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