(14 days)
Non-prescription sunglasses are for general use to protect eyes from strong sunlight
Not Found
The provided text is a 510(k) premarket notification approval letter from the FDA for "Sunglasses." This type of document is a regulatory approval, not a scientific study describing device performance and acceptance criteria.
Therefore, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, etc.) can be extracted from the provided text. The letter simply states that the device (sunglasses) is substantially equivalent to legally marketed predicate devices and can proceed to market.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/0/Picture/3 description: The image shows a date, "DEC - 8 1997". The month is December, the day is the 8th, and the year is 1997. The text is in a bold, sans-serif font. The background is white.
Mr. Alexander B. Kim President Morning Calm Corp. 1106 Seong An Officetel 87-36, Duryu- 2Dong, Dalseo-Gu Daegu, 704-062 Korea
Re: K974414
Trade Name: Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: November 13, 1997 Received: November 24, 1997
Dear Mr. Kim:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Alexander B. Kim
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 40(k) Number (if known): | K974414 |
|---|---|
| Device Name: | Sunglasses |
| Indications For Use: | Non-prescription sunglasses are for general use to protect eyes from strong sunlight |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Am Williams
(Division Sign-Off)
Division of Ophthalmic Devices
Division of Ophthalmic Devices
510(k) Number K974414
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Over-The-Counter Use ✓
§ 886.5850 Sunglasses (nonprescription).
(a)
Identification. Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.