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FDA 510(k)

LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL

K-Number: K855146 · 1986-04-11

ApplicantLaserscope
Decision Date1986-04-11
Product CodeLMS
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1986-04-11 under 510(k) number K855146. The device is classified under product code LMS. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL?

LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is Laserscope. The 510(k) number is K855146.

When did LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL receive FDA 510(k) clearance?

LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL received FDA 510(k) clearance on 1986-04-11, under 510(k) number K855146.

Who is the listed applicant for LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL?

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 OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL?

The FDA product code for LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL is LMS.

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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: LMS)

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.

K871424ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASERHgm, 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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