← Product Code [HLJ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ) · K052599 # 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A (K052599) _Suzhou 66 Vision Tech Co., Ltd. · HLJ · Nov 7, 2006 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K052599 ## Device Facts - **Applicant:** Suzhou 66 Vision Tech Co., Ltd. - **Product Code:** [HLJ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ.md) - **Decision Date:** Nov 7, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.1570 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## 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. ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. 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. {1}------------------------------------------------ ## 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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 {2}------------------------------------------------ ## 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. ## (PLEASE DO NOT WRITE BELOW THIS LINE ) 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K052599](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K052599) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com