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FDA 510(k)

MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE

K-Number: K850728 · 1985-04-08

ApplicantCooper Lasersonics, Inc.
Decision Date1985-04-08
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Lasersonics, Inc.. It received FDA 510(k) clearance on 1985-04-08 under 510(k) number K850728. 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 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE?

MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE is a medical device that received FDA 510(k) clearance on 1985-04-08. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K850728.

When did MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE receive FDA 510(k) clearance?

MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE received FDA 510(k) clearance on 1985-04-08, under 510(k) number K850728.

Who is the listed applicant for MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE?

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

What is the FDA product code for MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE?

The FDA product code for MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE is LNK.

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Other records listing Cooper Lasersonics, 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.

K880808ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SUK880807ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SUK880427ILLUMINA 40 CO2 LASER SYSTEMK880428ILLUMINA 25 CO2 LASER SYSTEMK880429ILLUMINA 55 CO2 LASER SYSTEMK880809ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU

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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.K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.Minnesota Laser Corp.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.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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