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FDA 510(k)

OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION

K-Number: K902263 · 1990-07-23

ApplicantTrimedyne, Inc.
Decision Date1990-07-23
Product CodeGGX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1990-07-23 under 510(k) number K902263. The device is classified under product code GGX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION?

OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION is a medical device that received FDA 510(k) clearance on 1990-07-23. The listed applicant is Trimedyne, Inc.. The 510(k) number is K902263.

When did OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION receive FDA 510(k) clearance?

OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION received FDA 510(k) clearance on 1990-07-23, under 510(k) number K902263.

Who is the listed applicant for OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION?

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 MODEL 1000 ND:YAG LASER ADD'L INDICATION?

The FDA product code for OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION is GGX.

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Other records listing Trimedyne, Inc. as applicant

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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: GGX)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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