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

K013511 · Aculux, Inc. · FSW · Feb 1, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013511
• Device Name: XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)
• Applicant: Aculux, Inc.
• Product Code: FSW · General, Plastic Surgery
• Decision Date: Feb 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field. This light is utilized in many different surgical procedures requiring additional light when overhead lighting is not sufficient. The fiberoptic cable and/or headlamps are an accessory to the XenaLight™ Fiberoptic Illuminator to transmit the light from the lightsource.

Device Story

XenaLight™ Fiberoptic Illuminator functions as a surgical light source; provides illumination to surgical operating fields. Device connects to fiberoptic cables which transmit light to headlamps, retractors, or endoscopic instruments. Used in clinical/surgical settings to supplement overhead lighting. Operated by surgeons or surgical staff. Benefits include improved visibility during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fiberoptic light source; utilizes fiberoptic cables for light transmission to surgical instruments. Class II device (21 CFR 878.4580).

Indications for Use

Indicated for use in surgical procedures requiring supplemental illumination of the operating field via fiberoptic headlamps, retractors, or endoscopic instruments.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

Ms. Kim Marsh President AcuLux, Inc. 273 South Airport Pulling Road Naples, Florida 34104

Re: K013511

K013911
Trade/Device Name: XENALight™ Fiberoptic Illuminator Regulation Number: 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSW Dated: January 8, 2002 Received: January 9, 2002

Dear Ms. Marsh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premium is substantially equivalent (for the indications felerenced above and nave decembers and and and and and one marketed in interstate for use stated in the encrosure) to regars) at tegally and the Medical Device American be on the col. Fored. Fores commerce prior to May 20, 1976, the enaounce with the provisions of the Federal Food, Drug, devices that have been recassinou in accera approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The 1 ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classinonal controls. Existing major regulations affecting your device can may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oe advisou that I Dri brassan that your device complies with other requirements of the Act that I Drillas made a sond regulations administered by other Federal agencies. You must of any I cacal statutes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Part 807), accimig (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by sellions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kim Marsh

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in you'll ought inding of substantial equivalence of your device to a legally prematicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific arra 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 - 11 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -Compliance at [phone] ffice of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation catured, "Misormation of esponsibilities under the Act may be obtained from the Outcr general mionmation the mational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

## STATEMENT

DEVICE NAME: XenaLight™ Fiberoptic Illuminator

The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field. This light is utilized in many different surgical procedures requiring additional light when overhead lighting is not sufficient.

The fiberoptic cable and/or headlamps are an accessory to the XenaLight™ Fiberoptic Illuminator to transmit the light from the lightsource.

Kim Marsh, President

Oct. 19 2001

October 19, 2001

Miriam C. Provost

Restorative Neurological L .. vices

510(k) Number K013511

*(Premarket Notification 510(k)