LED LAMP OR OTHER

K092883 · Intravista Medical Systems, Inc. · HJO · Dec 18, 2009 · Ophthalmic

Device Facts

• Record ID: K092883
• Device Name: LED LAMP OR OTHER
• Applicant: Intravista Medical Systems, Inc.
• Product Code: HJO · Ophthalmic
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The Vivid Light™ LED lamps for slit lamp biomicroscope are intended to be used as accessories for replacement of the 6V Tungsten bulb for Haag Streit's BM900, BQ900, BX900 and BP900 slit lamp biomicroscopes. Haag Streit's slit lamp biomicroscopes are indicated as noninvasive aid to the examination and diagnosis of eye conditions and in fitting of contact lenses.

Device Story

Vivid Light™ LED lamp serves as a replacement accessory for 6V Tungsten bulbs in specific Haag Streit slit lamp biomicroscopes. Device functions as an illumination source for clinical ophthalmic examinations; enables visualization of ocular structures for diagnosis and contact lens fitting. Used in clinical settings by eye care professionals. Replaces traditional incandescent lighting with LED technology to provide illumination for the slit lamp's optical system.

Clinical Evidence

Bench testing only.

Technological Characteristics

LED-based illumination source; designed as a direct replacement for 6V Tungsten bulbs in Haag Streit BM900, BQ900, BX900, and BP900 slit lamp biomicroscopes. Operates as an accessory to existing ophthalmic diagnostic equipment.

Indications for Use

Indicated for use as a replacement light source for Haag Streit slit lamp biomicroscopes (BM900, BQ900, BX900, BP900) to aid in the noninvasive examination and diagnosis of eye conditions and the fitting of contact lenses.

Regulatory Classification

Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Special Controls

*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

IntraVista Medical Systems. Inc. c/o Wei Su, Ph.D. Chairman and CEO 1567 Samedra Street Sunnyvale, CA 94087

DEC 1 8 2009

Re: K092883

Trade/Device Name: Vivid Light™ LED lamp Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Bio-microscope Regulatory Class: II Product Code: HJO Dated: November 16, 2009 Received: November 23, 2009

Dear Dr. Su:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of -Surveillance-and-Biometrics/Division-of-Postmarket-Surveillance .--

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,

Kenia Alexander Jr.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K092883

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Vivid Light™ LED lamps for slit lamp biomicroscope Device Name:

Indications For Use: The Vivid Light™ LED lamps for slit lamp biomicroscope are intended to be used as accessories for replacement of the 6V Tungsten bulb for Haag Streit's BM900, BQ900, BX900 and BP900 slit lamp biomicroscopes. Haag Streit's slit lamp biomicroscopes are indicated as noninvasive aid to the examination and diagnosis of eye conditions and in fitting of contact lenses.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

the 1

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K092883 510(k) Number.