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FDA 510(k)

LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER

K-Number: K862005 · 1986-08-29

ApplicantLaserscope
Decision Date1986-08-29
Product CodeEWG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1986-08-29 under 510(k) number K862005. The device is classified under product code EWG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER?

LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER is a medical device that received FDA 510(k) clearance on 1986-08-29. The listed applicant is Laserscope. The 510(k) number is K862005.

When did LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER receive FDA 510(k) clearance?

LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER received FDA 510(k) clearance on 1986-08-29, under 510(k) number K862005.

Who is the listed applicant for LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER?

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 SYSTEM/CO2 LASER?

The FDA product code for LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER is EWG.

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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: EWG)

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.

K924652BENSON CCA100Benson Medical Instruments Co.K870587LASERMATIC SURGILASER MODEL 5050Lasermatic OYK880428ILLUMINA 25 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880427ILLUMINA 40 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880429ILLUMINA 55 CO2 LASER SYSTEMCooper Lasersonics, Inc.K872710MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROATDirected Energy, 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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