HQY · Sunglasses (Non-Prescription Including Photosensitive)
Ophthalmic · 21 CFR 886.5850 · Class 1
Overview
| Product Code | HQY |
|---|---|
| Device Name | Sunglasses (Non-Prescription Including Photosensitive) |
| Regulation | 21 CFR 886.5850 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Classification Rationale
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.
Recent Cleared Devices (20 of 646)
Showing 20 most recent of 646 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974860 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Ming Ming Optical Co. , Ltd. | Jan 30, 1998 | SESE |
| K974852 | NON-PRESCRIPTION SUNGLASSES | Chia Hui Spectacles Mfg. Corp. | Jan 30, 1998 | SESE |
| K974861 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Hindar Optical Co., Ltd. | Jan 27, 1998 | SESE |
| K974511 | SUNGLASSES | Sun World Intl., Inc. | Jan 12, 1998 | SESE |
| K974441 | SUNGLASSES | Hip Shing Fat Co., Ltd. | Jan 9, 1998 | SESE |
| K974414 | MULTI | Morning Calm Corp. | Dec 8, 1997 | SESE |
| K973528 | SUNGLASSES | Jeou Jeou Long Industrial Co., Ltd. | Dec 8, 1997 | SESE |
| K974179 | NON-PRESCRIPTION SUNGLASSES | Taipan Optical Company , Ltd. | Dec 1, 1997 | SESE |
| K974045 | VENNETO | Amsure Sports, Inc. | Nov 20, 1997 | SESE |
| K973934 | SUNGLASSES | Elegance Optical Manufactory, Ltd. | Nov 18, 1997 | SESE |
| K973526 | SUNGLASSES | Pyramid Handbags, Inc. | Oct 16, 1997 | SESE |
| K973490 | SUNGLASSES | Tong Yang Optical Co. | Sep 30, 1997 | SESE |
| K973407 | SUNGLASSES (NON-PRESCRIPTION) | Pacific Optical Co. , Ltd. | Sep 30, 1997 | SESE |
| K973016 | NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS | Optimaxx Intl. | Sep 17, 1997 | SESE |
| K972850 | SUNGLASSES | Indoptica, S.A. | Sep 17, 1997 | SESE |
| K972717 | RUFF WORK EYEGEAR | Ruff House, Inc. | Aug 25, 1997 | SESE |
| K972590 | NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES | Lbi U.S.A. | Jul 31, 1997 | SESE |
| K972490 | D'ARC EYE CARE SUNGLASSES | M & R Dist. | Jul 25, 1997 | SESE |
| K972416 | MOMO DESIGN OR MOMO | Momo U.S.A., Inc. | Jul 21, 1997 | SESE |
| K972362 | FOVS, BRILLARTE, ETC... | Sunglass City, Inc. | Jul 14, 1997 | SESE |
Top Applicants
- J & B Assoc. — 10 clearances
- The Orvis Co., Inc. — 9 clearances
- Blublocker Corp. — 7 clearances
- Sunny Sunglasses — 6 clearances
- Yorktowne Optical Co., Inc. — 5 clearances
