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FDA 510(k)

OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO

K-Number: K861173 · 1986-07-25

ApplicantTrimedyne, Inc.
Decision Date1986-07-25
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1986-07-25 under 510(k) number K861173. 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 OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO?

OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO is a medical device that received FDA 510(k) clearance on 1986-07-25. The listed applicant is Trimedyne, Inc.. The 510(k) number is K861173.

When did OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO receive FDA 510(k) clearance?

OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO received FDA 510(k) clearance on 1986-07-25, under 510(k) number K861173.

Who is the listed applicant for OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO?

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

What is the FDA product code for OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO?

The FDA product code for OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO is LNK.

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Other records listing Trimedyne, 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.

K053457VAPORMAX IIK050412VAPORMAXK043012OMNIPULSE MINI, MODEL 2120K041660TRIMEDYNE HOLMIUM LASER SYSTEMSK022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATHK013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A

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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.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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