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FDA 510(k)

SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE

K-Number: K871348 · 1987-06-12

ApplicantSharplan Lasers, Inc.
Decision Date1987-06-12
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE is the device name listed in this FDA 510(k) record. The listed applicant is Sharplan Lasers, Inc.. It received FDA 510(k) clearance on 1987-06-12 under 510(k) number K871348. 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 SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE?

SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE is a medical device that received FDA 510(k) clearance on 1987-06-12. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K871348.

When did SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE receive FDA 510(k) clearance?

SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE received FDA 510(k) clearance on 1987-06-12, under 510(k) number K871348.

Who is the listed applicant for SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE?

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

What is the FDA product code for SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE?

The FDA product code for SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE is LNK.

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Other records listing Sharplan Lasers, Inc. 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.

K973354SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K972099SHARPLAN EPITOUCH RUBY LASER SYSTEMK971874SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K971648SHARPLAN ERBIUM: YAG LASER (4020)K971743SHARPLAN CO2 SURGICAL LASER SYSTEMK962446SHARPLAN RUBY LASER SYSTEM

View all 78 devices →

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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