Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5850](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5850) → HQY — Sunglasses (Non-Prescription Including Photosensitive) # HQY · Sunglasses (Non-Prescription Including Photosensitive) _Ophthalmic · 21 CFR 886.5850 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY ## Overview - **Product Code:** HQY - **Device Name:** Sunglasses (Non-Prescription Including Photosensitive) - **Regulation:** [21 CFR 886.5850](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5850) - **Device Class:** 1 - **Review Panel:** [Ophthalmic](/submissions/OP) ## 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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K974860.md) | NON-PRESCRIPTION SUNGLASSES | Wenzhou Ming Ming Optical Co. , Ltd. | Jan 30, 1998 | SESE | | [K974852](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K974852.md) | NON-PRESCRIPTION SUNGLASSES | Chia Hui Spectacles Mfg. Corp. | Jan 30, 1998 | SESE | | [K974861](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K974861.md) | NON-PRESCRIPTION SUNGLASSES | Wenzhou Hindar Optical Co., Ltd. | Jan 27, 1998 | SESE | | [K974511](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K974511.md) | SUNGLASSES | Sun World Intl., Inc. | Jan 12, 1998 | SESE | | [K974441](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K974441.md) | SUNGLASSES | Hip Shing Fat Co., Ltd. | Jan 9, 1998 | SESE | | [K974414](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K974414.md) | MULTI | Morning Calm Corp. | Dec 8, 1997 | SESE | | [K973528](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K973528.md) | SUNGLASSES | Jeou Jeou Long Industrial Co., Ltd. | Dec 8, 1997 | SESE | | [K974179](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K974179.md) | NON-PRESCRIPTION SUNGLASSES | Taipan Optical Company , Ltd. | Dec 1, 1997 | SESE | | [K974045](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K974045.md) | VENNETO | Amsure Sports, Inc. | Nov 20, 1997 | SESE | | [K973934](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K973934.md) | SUNGLASSES | Elegance Optical Manufactory, Ltd. | Nov 18, 1997 | SESE | | [K973526](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K973526.md) | SUNGLASSES | Pyramid Handbags, Inc. | Oct 16, 1997 | SESE | | [K973490](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K973490.md) | SUNGLASSES | Tong Yang Optical Co. | Sep 30, 1997 | SESE | | [K973407](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K973407.md) | SUNGLASSES (NON-PRESCRIPTION) | Pacific Optical Co. , Ltd. | Sep 30, 1997 | SESE | | [K973016](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K973016.md) | NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS | Optimaxx Intl. | Sep 17, 1997 | SESE | | [K972850](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K972850.md) | SUNGLASSES | Indoptica, S.A. | Sep 17, 1997 | SESE | | [K972717](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K972717.md) | RUFF WORK EYEGEAR | Ruff House, Inc. | Aug 25, 1997 | SESE | | [K972590](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K972590.md) | NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES | Lbi U.S.A. | Jul 31, 1997 | SESE | | [K972490](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K972490.md) | D'ARC EYE CARE SUNGLASSES | M & R Dist. | Jul 25, 1997 | SESE | | [K972416](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K972416.md) | MOMO DESIGN OR MOMO | Momo U.S.A., Inc. | Jul 21, 1997 | SESE | | [K972362](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K972362.md) | 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 - Ja-Ru, Inc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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