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FDA 510(k)

MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE

K-Number: K880256 · 1988-04-14

ApplicantSharplan Lasers, Inc.
Decision Date1988-04-14
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY 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 1988-04-14 under 510(k) number K880256. 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 MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE?

MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE is a medical device that received FDA 510(k) clearance on 1988-04-14. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K880256.

When did MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE receive FDA 510(k) clearance?

MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE received FDA 510(k) clearance on 1988-04-14, under 510(k) number K880256.

Who is the listed applicant for MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY 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 MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE?

The FDA product code for MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY 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.K880193MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USESharplan Lasers, Inc.K875039ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGYSurgilase, 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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