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FDA 510(k)

IMS5000 ILLUMINATED LOUPES

K-Number: K895248 · 1989-09-15

ApplicantLuxtec Corp.
Decision Date1989-09-15
Product CodeFSP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMS5000 ILLUMINATED LOUPES is the device name listed in this FDA 510(k) record. The listed applicant is Luxtec Corp.. It received FDA 510(k) clearance on 1989-09-15 under 510(k) number K895248. The device is classified under product code FSP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMS5000 ILLUMINATED LOUPES?

IMS5000 ILLUMINATED LOUPES is a medical device that received FDA 510(k) clearance on 1989-09-15. The listed applicant is Luxtec Corp.. The 510(k) number is K895248.

When did IMS5000 ILLUMINATED LOUPES receive FDA 510(k) clearance?

IMS5000 ILLUMINATED LOUPES received FDA 510(k) clearance on 1989-09-15, under 510(k) number K895248.

Who is the listed applicant for IMS5000 ILLUMINATED LOUPES?

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

What is the FDA product code for IMS5000 ILLUMINATED LOUPES?

The FDA product code for IMS5000 ILLUMINATED LOUPES is FSP.

Related Clinical Trials

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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Other records listing Luxtec Corp. 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.

K973193LUXSCOPEK970642TENOSCOPEK970562TENOSNAREK950960REDDY ILLUMINATORK890716LUXTEC ACO SERIES 4000 LIGHT SOURCEK864387LUXTEC FIBEROPTIC CABLES

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Related Devices (Code: FSP)

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.

K891895SURGICAL LOUPESZinnanti Surgical Instruments, Inc.K864386LUXTEC LOUPES FOR SURGICAL VISIONLuxtec Corp.K8617493X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCEKeeler Instruments, 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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