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FDA 510(k)

MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER

K-Number: K944626 · 1994-11-03

ApplicantMnlase, Inc.
Decision Date1994-11-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER is the device name listed in this FDA 510(k) record. The listed applicant is Mnlase, Inc.. It received FDA 510(k) clearance on 1994-11-03 under 510(k) number K944626. 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 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER?

MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER is a medical device that received FDA 510(k) clearance on 1994-11-03. The listed applicant is Mnlase, Inc.. The 510(k) number is K944626.

When did MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER receive FDA 510(k) clearance?

MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER received FDA 510(k) clearance on 1994-11-03, under 510(k) number K944626.

Who is the listed applicant for MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER?

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

What is the FDA product code for MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER?

The FDA product code for MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Mnlase, 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.

K944630MODEL 230-SAS LASER DELIVERY PROBEK944625MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASERK944628MODEL 220-SS LASER DELIVERY PROBEK944470CURVED ENDOPHOTOCOAGULATOR LASER PROBEK944471STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBEK944629MODEL 230-SAC LASER DELIVERY PROBE

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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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