66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A

K052599 · Suzhou 66 Vision Tech Co., Ltd. · HLJ · Nov 7, 2006 · Ophthalmic

Device Facts

• Record ID: K052599
• Device Name: 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
• Applicant: Suzhou 66 Vision Tech Co., Ltd.
• Product Code: HLJ · Ophthalmic
• Decision Date: Nov 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The 66 Vision Tech Ophthalmoscopes (Indirect and Direct) are intended to examine the cornea, aqueous, lens and vitreous and the retina of the eye.

Device Story

66 Vision Tech Ophthalmoscopes (Models YZ6E, YZ6F, YZ6G, YZ11, YZ11D, YZ25A) are handheld diagnostic instruments used by eye care professionals to visualize internal eye structures. Direct models (YZ6 series, YZ11 series) and indirect model (YZ25A) utilize battery or AC power to illuminate and magnify the cornea, aqueous, lens, vitreous, and retina. The device provides a magnified view of the ocular fundus, allowing clinicians to assess ocular health and identify pathologies. Used in clinical settings, the device output is a direct optical image viewed by the physician through the eyepiece. No digital processing or automated analysis is involved.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Handheld ophthalmoscopes; direct and indirect optical configurations. Power source: Battery or AC-powered. Components include illumination system, lenses, and viewing aperture. Materials and construction conform to standard ophthalmic diagnostic device specifications. No software or digital processing components.

Indications for Use

Indicated for examination of the cornea, aqueous, lens, vitreous, and retina of the eye in patients requiring ophthalmic evaluation.

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, 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 9200 Corporate Boulevard Rockville MD 20850

Suzhou 66 Vision Tech Co., Ltd. c/o Mr. Gong Bo Shanghai Q Rai Consultant Co., Ltd. 600/8/503 Liuzhou Road Shanghai

NOV - 7 2006

Re: K052599

Trade/Device Name: 66 Vision Tech Ophthalmoscopes and Accessories Models: YZ6E, YZ6F, YZ6G, YZ11, YZ11D (Direct) and YZ25A (Indirect) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, Battery-Powered, Ophthalmoscope, AC-Powered Regulatory Class: Class II Product Code: HLJ: HLL Dated: October 18, 2006 Received: October 24, 2006

Dear Mr. Bo:

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. Gong Bo

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,

M.B. Eichelman Si MD

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

Enclosure

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## Section 4. Statement of Indications for Use

4.1 510K Number: K052599

4.2 Device Trade Name: 66 Vision Tech Ophthalmoscope

4.3 Indications For Use:

The 66 Vision Tech Ophthalmoscopes (Indirect and Direct) are intended to examine the cornea, aqueous, lens and vitreous and the retina of the eye.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use _____________

Marsha L. Burke Hi cholas

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

510(k) Number