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FDA 510(k)

LUTEX HEADLIGHT SYSTEMS

K-Number: K864380 · 1986-11-19

ApplicantLuxtec Corp.
Decision Date1986-11-19
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUTEX HEADLIGHT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Luxtec Corp.. It received FDA 510(k) clearance on 1986-11-19 under 510(k) number K864380. The device is classified under product code FST. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUTEX HEADLIGHT SYSTEMS?

LUTEX HEADLIGHT SYSTEMS is a medical device that received FDA 510(k) clearance on 1986-11-19. The listed applicant is Luxtec Corp.. The 510(k) number is K864380.

When did LUTEX HEADLIGHT SYSTEMS receive FDA 510(k) clearance?

LUTEX HEADLIGHT SYSTEMS received FDA 510(k) clearance on 1986-11-19, under 510(k) number K864380.

Who is the listed applicant for LUTEX HEADLIGHT SYSTEMS?

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 LUTEX HEADLIGHT SYSTEMS?

The FDA product code for LUTEX HEADLIGHT SYSTEMS is FST.

Related Clinical Trials

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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: FST)

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.

K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndInnovasis, Inc.K122637LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999Stryker SpineK113697EIGR SURGICAL ILLUMINATION SYSTEMInvuity, Inc.K113330CABLECAPSensormedK102266ISOLED AC-POWERED LED HEADLIGHT SYSTEMIsolux, LLCK101496CABLECAP MODEL: WLF, STZ, ACMSensormed

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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