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FDA 510(k)

LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM

K-Number: K864381 · 1986-12-09

ApplicantLuxtec Corp.
Decision Date1986-12-09
Product CodeFWC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Luxtec Corp.. It received FDA 510(k) clearance on 1986-12-09 under 510(k) number K864381. The device is classified under product code FWC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM?

LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 1986-12-09. The listed applicant is Luxtec Corp.. The 510(k) number is K864381.

When did LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM receive FDA 510(k) clearance?

LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM received FDA 510(k) clearance on 1986-12-09, under 510(k) number K864381.

Who is the listed applicant for LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM?

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 LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM?

The FDA product code for LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM is FWC.

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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 ILLUMINATORK895248IMS5000 ILLUMINATED LOUPESK890716LUXTEC ACO SERIES 4000 LIGHT SOURCE

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Related Devices (Code: FWC)

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.

K890119BR-S601MU (SURGICAL VIDEO RECORDER)Victor Co. of Japan, Ltd. C/O Jvc Corp.K854988KY-M280U SURGICAL CAMERAUs Jvc Corp.

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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