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K Number
K973528
Device Name
SUNGLASSES
Manufacturer
JEOU JEOU LONG INDUSTRIAL CO., LTD.
Date Cleared
1997-12-08

(82 days)

Product Code
HQY
Regulation Number
886.5850
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) clearance letter for "Sunglasses" (non-prescription) and an "Indications For Use" statement. It does not contain information about acceptance criteria for a medical device or a study proving that a device meets such criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given text.

The document primarily focuses on:

  • Device: Sunglasses (non-prescription)
  • Regulatory Classification: Class I, Product Code 86 HQY
  • Indication for Use: To protect eyes from bright sunlight, not for refractive corrections, usually available over-the-counter.
  • Regulatory Decision: Substantially equivalent to pre-amendment devices, subject to general controls.

§ 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.