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FDA 510(k)

COMBOLASER MODEL 5050

K-Number: K893529 · 1989-06-08

ApplicantLasermatic, Inc.
Decision Date1989-06-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMBOLASER MODEL 5050 is the device name listed in this FDA 510(k) record. The listed applicant is Lasermatic, Inc.. It received FDA 510(k) clearance on 1989-06-08 under 510(k) number K893529. 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 COMBOLASER MODEL 5050?

COMBOLASER MODEL 5050 is a medical device that received FDA 510(k) clearance on 1989-06-08. The listed applicant is Lasermatic, Inc.. The 510(k) number is K893529.

When did COMBOLASER MODEL 5050 receive FDA 510(k) clearance?

COMBOLASER MODEL 5050 received FDA 510(k) clearance on 1989-06-08, under 510(k) number K893529.

Who is the listed applicant for COMBOLASER MODEL 5050?

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 COMBOLASER MODEL 5050?

The FDA product code for COMBOLASER MODEL 5050 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 SYSTEMK901638MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33K871875MODEL 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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