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FDA 510(k)

XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)

K-Number: K013511 · 2002-02-01

ApplicantAculux, Inc.
Decision Date2002-02-01
Product CodeFSW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) is the device name listed in this FDA 510(k) record. The listed applicant is Aculux, Inc.. It received FDA 510(k) clearance on 2002-02-01 under 510(k) number K013511. The device is classified under product code FSW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)?

XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) is a medical device that received FDA 510(k) clearance on 2002-02-01. The listed applicant is Aculux, Inc.. The 510(k) number is K013511.

When did XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) receive FDA 510(k) clearance?

XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) received FDA 510(k) clearance on 2002-02-01, under 510(k) number K013511.

Who is the listed applicant for XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)?

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

What is the FDA product code for XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)?

The FDA product code for XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) is FSW.

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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Related Devices (Code: FSW)

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.

K022989RADLITE TISSUE RETRACTOR SYSTEMGenzyme BiosurgeryK943342MEDICAM XENON LIGHT SOURCEM.P. Video, Inc.K934337CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCECuda Products Co.K922279ILLUMINATOR IV MINOR SURGERY LIGHTMedical Illumination, Inc.K913135LM-300TWINLeisegang Medical, Inc.K894319MEDICAL DYNAMICS LIGHT SOURCEMedical Dynamics, 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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