LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES

K053227 · Medical Illumination International, Inc. · FST · Jan 13, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053227
• Device Name: LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES
• Applicant: Medical Illumination International, Inc.
• Product Code: FST · General, Plastic Surgery
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The Medical Illumination International Inc. 150 - 300 Watt Medical Fiberoptic Light Source with Headlight is indicated for use in transmitting light for illumination purposes from an illuminator (150 - 300 Watt Lamp) to various instruments such as a Headlight, providing illumination in body cavities during examinations or minimal invasive surgical procedures.

Device Story

Device consists of 150-300 Watt medical fiberoptic light source and headlight; functions by transmitting light from lamp through fiberoptic cables to surgical site; used in clinical settings (examinations, minimally invasive surgery) by physicians; provides illumination for visualization of body cavities; benefits patient by improving visibility during procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

150-300 Watt lamp; fiberoptic light transmission; standalone light source unit; intended for use with medical headlights; class II device (21 CFR 876.1500).

Indications for Use

Indicated for illumination of body cavities during examinations or minimally invasive surgical procedures via fiberoptic transmission of light from a 150-300 Watt lamp to a headlight or similar instrument.

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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JAN 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mike Alcala Manager, Quality Assurance and Regulatory Approval Medical Illumination International, Inc. 547 Library Street San Fernando, California 91340

Re: K053227

Trade/Device Name: 150 – 300 Watt Medical Fiberoptic Light Source Illuminating Headlights Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FST Dated: January 6, 2006 Received: January 6, 2005

Dear Mr. Alcala:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Alcala

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millhouser

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## VII Statement of Indications for Use

510(k) Number (if known): K053227

150 - 300 Watt Medical Fiberoptic Light Source Illuminating Device Name: Headlights.

Indications for use:

The Medical Illumination International Inc. 150 - 300 Watt Medical Fiberoptic Light Source with Headlight is indicated for use in transmitting light for illumination purposes from an illuminator (150 - 300 Watt Lamp) to various instruments such as a Headlight, providing illumination in body cavities during examinations or minimal invasive surgical procedures.

Prescription Use _YES__ and / or Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_ につらろ222