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FDA 510(k)

MODEL JM-1 CO2 LASER

K-Number: K892912 · 1990-03-06

ApplicantL.A.S.E.R., Inc.
Decision Date1990-03-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL JM-1 CO2 LASER is the device name listed in this FDA 510(k) record. The listed applicant is L.A.S.E.R., Inc.. It received FDA 510(k) clearance on 1990-03-06 under 510(k) number K892912. 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 JM-1 CO2 LASER?

MODEL JM-1 CO2 LASER is a medical device that received FDA 510(k) clearance on 1990-03-06. The listed applicant is L.A.S.E.R., Inc.. The 510(k) number is K892912.

When did MODEL JM-1 CO2 LASER receive FDA 510(k) clearance?

MODEL JM-1 CO2 LASER received FDA 510(k) clearance on 1990-03-06, under 510(k) number K892912.

Who is the listed applicant for MODEL JM-1 CO2 LASER?

The FDA 510(k) record lists L.A.S.E.R., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL JM-1 CO2 LASER?

The FDA product code for MODEL JM-1 CO2 LASER is GEX. This falls under the Gastroenterology category.

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Other records listing L.A.S.E.R., 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.

K983965CO2 LASER COUPLERK950021REUSABLE TROCAR WITH SAFETY SLEEVEK940454GRASPING FORCEPS, PUNCHES, SCISSORSK931561TROCAR SLEEVEK933421ENDOSCOPIC INSTRUMENTS AND ACCESSDORIESK924844BULK TISSUE REMOVAL SYSTEM

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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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