Product code HQY
- Device name
- Sunglasses (Non-Prescription Including Photosensitive)
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.5850
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974860 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Ming Ming Optical Co. , Ltd. | 1998-01-30 |
| K974852 | NON-PRESCRIPTION SUNGLASSES | Chia Hui Spectacles Mfg. Corp. | 1998-01-30 |
| K974861 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Hindar Optical Co., Ltd. | 1998-01-27 |
| K974511 | SUNGLASSES | Sun World Intl., Inc. | 1998-01-12 |
| K974441 | SUNGLASSES | Hip Shing Fat Co., Ltd. | 1998-01-09 |
| K974414 | MULTI | Morning Calm Corp. | 1997-12-08 |
| K973528 | SUNGLASSES | Jeou Jeou Long Industrial Co., Ltd. | 1997-12-08 |
| K974179 | NON-PRESCRIPTION SUNGLASSES | Taipan Optical Company , Ltd. | 1997-12-01 |
| K974045 | VENNETO | Amsure Sports, Inc. | 1997-11-20 |
| K973934 | SUNGLASSES | Elegance Optical Manufactory, Ltd. | 1997-11-18 |
| K973526 | SUNGLASSES | Pyramid Handbags, Inc. | 1997-10-16 |
| K973490 | SUNGLASSES | Tong Yang Optical Co. | 1997-09-30 |
| K973407 | SUNGLASSES (NON-PRESCRIPTION) | Pacific Optical Co. , Ltd. | 1997-09-30 |
| K973016 | NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS | Optimaxx Intl. | 1997-09-17 |
| K972850 | SUNGLASSES | Indoptica, S.A. | 1997-09-17 |
| K972717 | RUFF WORK EYEGEAR | Ruff House, Inc. | 1997-08-25 |
| K972590 | NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES | Lbi U.S.A. | 1997-07-31 |
| K972490 | D'ARC EYE CARE SUNGLASSES | M & R Dist. | 1997-07-25 |
| K972416 | MOMO DESIGN OR MOMO | Momo U.S.A., Inc. | 1997-07-21 |
| K972362 | FOVS, BRILLARTE, ETC... | Sunglass City, Inc. | 1997-07-14 |
| K971385 | SUNGLASSES | Kosway Industries Co., Ltd. | 1997-07-14 |
| K971384 | (BRAND NAME) | Long IN Time Ent. Co., Ltd. | 1997-07-01 |
| K971462 | SUNGLASSES | D.G. Prove Co. | 1997-07-01 |
| K972246 | SPECTACLE FRAMES (NON-PRESCRIPTION) | Alimar Trading, Inc. | 1997-06-26 |
| K971644 | CEBE | Suunto USA | 1997-06-24 |
| K972194 | RIVIERA SUNGLASS4ES | Riviera Optical Co., Ltd. | 1997-06-24 |
| K972014 | SUNGLASSES (NON-PRESCRIPTION) | Tamfort, Ltd. | 1997-06-24 |
| K971087 | SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC) | W.J. Byrnes & Co. of Los Angeles, Inc. | 1997-06-13 |
| K971707 | SUNGLASSES (NON-PRESCRIPTION) | Niko Sunglasses Corp. | 1997-06-13 |
| K971875 | OPTIM-EYES 450 | Taylor/Fox Enterprises, LLC | 1997-06-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06973541158315 | Sunglasses | Taizhou YuanMing Glasses Co., Ltd | 2026-06-02 |
| 06973541158322 | Sunglasses | Taizhou YuanMing Glasses Co., Ltd | 2026-06-02 |
| 06973541158339 | Sunglasses | Taizhou YuanMing Glasses Co., Ltd | 2026-06-02 |
| 06973541158346 | Sunglasses | Taizhou YuanMing Glasses Co., Ltd | 2026-06-02 |
| 08800332269951 | Blue Elephant | Blue Elephant Co.,Ltd. | 2026-06-02 |
| 00676190876697 | Superflex Sun Collection | WestGroupe Optical Inc | 2026-06-01 |
| 00676190876734 | Superflex Sun Collection | WestGroupe Optical Inc | 2026-06-01 |
| 00676190876772 | Superflex Sun Collection | WestGroupe Optical Inc | 2026-06-01 |
| 00881814539937 | Superflex Sun Collection | WestGroupe Optical Inc | 2026-06-01 |
| 00881814539975 | Superflex Sun Collection | WestGroupe Optical Inc | 2026-06-01 |
| 00881814540018 | Superflex Sun Collection | WestGroupe Optical Inc | 2026-06-01 |
| 08908016666635 | Sunglass | PRAMARA PROMOTIONS LIMITED | 2026-05-29 |
| 08908016666536 | Sunglass | PRAMARA PROMOTIONS LIMITED | 2026-05-29 |
| 08908016666505 | Sunglass | PRAMARA PROMOTIONS LIMITED | 2026-05-29 |
| 08908016666529 | Sunglass | PRAMARA PROMOTIONS LIMITED | 2026-05-29 |
| 08054342061078 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-14 |
| 08054342061047 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-14 |
| 08054342061030 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-14 |
| 08054342061023 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-14 |
| 08054342061016 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-14 |
| 08054342060965 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-13 |
| 08054342060972 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-13 |
| 08054342060989 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-13 |
| 08054342060996 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-13 |
| 08054342060958 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-13 |
| 08054342060934 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-13 |
| 08054342060927 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-13 |
| 08054342061061 | Bricola Venezia | MAD IN ITALY SRL | 2026-04-13 |
| 06974807120183 | BELL+HOWELL | WENZHOU SUNMAX INTERNATIONAL TRADE CO.,LTD | 2025-09-10 |
| 08012794011485 | BOLT&ARROW | LA GIARDINIERA SRL | 2023-01-24 |