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FDA 510(k)

ORS-2000 SERIES

K-Number: K921633 · 1992-06-02

ApplicantMnlase, Inc.
Decision Date1992-06-02
Product CodeLHC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORS-2000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Mnlase, Inc.. It received FDA 510(k) clearance on 1992-06-02 under 510(k) number K921633. The device is classified under product code LHC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORS-2000 SERIES?

ORS-2000 SERIES is a medical device that received FDA 510(k) clearance on 1992-06-02. The listed applicant is Mnlase, Inc.. The 510(k) number is K921633.

When did ORS-2000 SERIES receive FDA 510(k) clearance?

ORS-2000 SERIES received FDA 510(k) clearance on 1992-06-02, under 510(k) number K921633.

Who is the listed applicant for ORS-2000 SERIES?

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 ORS-2000 SERIES?

The FDA product code for ORS-2000 SERIES is LHC.

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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: LHC)

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.

K153713Getinge Series Warming CabinetGetinge Sourcing, LLCK152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc.K083417INTRATEMP SOLUTION WARMERC Change Surgical, LLCK080609SWC/DWC WARMING CABINETSMac MedicalK051819C CHANGE SOLUTION WARMERC Change Surgical, LLCK0232831075LD HUSH-SLUSHO.R. Solutions, Inc.

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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