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FDA 510(k)

LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM

K-Number: K854027 · 1985-12-02

ApplicantLaserscope
Decision Date1985-12-02
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1985-12-02 under 510(k) number K854027. The device is classified under product code LNK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM?

LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1985-12-02. The listed applicant is Laserscope. The 510(k) number is K854027.

When did LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM receive FDA 510(k) clearance?

LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM received FDA 510(k) clearance on 1985-12-02, under 510(k) number K854027.

Who is the listed applicant for LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM?

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

What is the FDA product code for LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM?

The FDA product code for LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM is LNK.

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Other records listing Laserscope 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.

K062719GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIESK061646LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIESK034011GEMINI SURGICAL LASER SYSTEM & ACCESSORIESK024206AURA ISURGICAL LASER SYSTEM & ACCESSORIESK020021LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)K010834LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES

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Related Devices (Code: LNK)

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.

K925395TECHNOMED PULSOLITH 4000 LASER SYSTEMTeknomed, Inc.K901723MDL-2000 LASERTRIPTERCandela Laser Corp.K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.Minnesota Laser Corp.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.Minnesota Laser Corp.K880256MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USESharplan Lasers, Inc.K880193MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USESharplan Lasers, 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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