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FDA 510(k)

OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN

K-Number: K863221 · 1987-03-02

ApplicantLaserscope
Decision Date1987-03-02
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1987-03-02 under 510(k) number K863221. The device is classified under product code HHR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN?

OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN is a medical device that received FDA 510(k) clearance on 1987-03-02. The listed applicant is Laserscope. The 510(k) number is K863221.

When did OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN receive FDA 510(k) clearance?

OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN received FDA 510(k) clearance on 1987-03-02, under 510(k) number K863221.

Who is the listed applicant for OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN?

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 OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN?

The FDA product code for OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN is HHR.

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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: HHR)

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.

K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.K871875MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.K875314GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.K874615LASER CANNISTER FILTERMedical Marketing, Inc.K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLCK880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, 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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