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FDA 510(k)

LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM

K-Number: K862598 · 1986-11-19

ApplicantLaserscope
Decision Date1986-11-19
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1986-11-19 under 510(k) number K862598. 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/SUPPLEM?

LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM is a medical device that received FDA 510(k) clearance on 1986-11-19. The listed applicant is Laserscope. The 510(k) number is K862598.

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

LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM received FDA 510(k) clearance on 1986-11-19, under 510(k) number K862598.

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

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/SUPPLEM?

The FDA product code for LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM 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.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.Minnesota Laser Corp.K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.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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