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FDA 510(k)

ISOLUX SURGICAL HEADLIGHT

K-Number: K991572 · 1999-07-08

ApplicantIsolux America
Decision Date1999-07-08
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLUX SURGICAL HEADLIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Isolux America. It received FDA 510(k) clearance on 1999-07-08 under 510(k) number K991572. 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 ISOLUX SURGICAL HEADLIGHT?

ISOLUX SURGICAL HEADLIGHT is a medical device that received FDA 510(k) clearance on 1999-07-08. The listed applicant is Isolux America. The 510(k) number is K991572.

When did ISOLUX SURGICAL HEADLIGHT receive FDA 510(k) clearance?

ISOLUX SURGICAL HEADLIGHT received FDA 510(k) clearance on 1999-07-08, under 510(k) number K991572.

Who is the listed applicant for ISOLUX SURGICAL HEADLIGHT?

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

What is the FDA product code for ISOLUX SURGICAL HEADLIGHT?

The FDA product code for ISOLUX SURGICAL HEADLIGHT is FST.

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 Isolux America 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.

K022384XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBPK991208ENDOSCOPIC FIBEROPTIC CABLE

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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