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FDA 510(k)

LUXSCOPE

K-Number: K973193 · 1997-11-21

ApplicantLuxtec Corp.
Decision Date1997-11-21
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LUXSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Luxtec Corp.. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K973193. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUXSCOPE?

LUXSCOPE is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Luxtec Corp.. The 510(k) number is K973193.

When did LUXSCOPE receive FDA 510(k) clearance?

LUXSCOPE received FDA 510(k) clearance on 1997-11-21, under 510(k) number K973193.

Who is the listed applicant for LUXSCOPE?

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 LUXSCOPE?

The FDA product code for LUXSCOPE is HQF.

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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.

K970642TENOSCOPEK970562TENOSNAREK950960REDDY ILLUMINATORK895248IMS5000 ILLUMINATED LOUPESK890716LUXTEC ACO SERIES 4000 LIGHT SOURCEK864387LUXTEC FIBEROPTIC CABLES

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Related Devices (Code: HQF)

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

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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