HQY — Sunglasses (Non-Prescription Including Photosensitive) Class I
FDA product code HQY covers "Sunglasses (Non-Prescription Including Photosensitive)", a Class I medical device regulated under 21 CFR 886.5850. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HQY
- Device Class
- Class I
- Regulation Number
- 886.5850
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974852 | chia hui spectacles mfg | NON-PRESCRIPTION SUNGLASSES | January 30, 1998 |
| K974860 | wenzhou ming ming optical co. | NON-PRESCRIPTION SUNGLASSES | January 30, 1998 |
| K974861 | wenzhou hindar optical co | NON-PRESCRIPTION SUNGLASSES | January 27, 1998 |
| K974511 | sun world intl | SUNGLASSES | January 12, 1998 |
| K974441 | hip shing fat co | SUNGLASSES | January 9, 1998 |
| K974414 | morning calm | MULTI | December 8, 1997 |
| K973528 | jeou jeou long industrial co | SUNGLASSES | December 8, 1997 |
| K974179 | taipan optical company | NON-PRESCRIPTION SUNGLASSES | December 1, 1997 |
| K974045 | amsure sports | VENNETO | November 20, 1997 |
| K973934 | elegance optical manufactory | SUNGLASSES | November 18, 1997 |
| K973526 | pyramid handbags | SUNGLASSES | October 16, 1997 |
| K973490 | tong yang optical | SUNGLASSES | September 30, 1997 |
| K973407 | pacific optical co. | SUNGLASSES (NON-PRESCRIPTION) | September 30, 1997 |
| K972850 | indoptica | SUNGLASSES | September 17, 1997 |
| K973016 | optimaxx intl | NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS | September 17, 1997 |
| K972717 | ruff house | RUFF WORK EYEGEAR | August 25, 1997 |
| K972590 | lbi u | NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES | July 31, 1997 |
| K972490 | m and r dist | D'ARC EYE CARE SUNGLASSES | July 25, 1997 |
| K972416 | momo u.s.a | MOMO DESIGN OR MOMO | July 21, 1997 |
| K971385 | kosway industries co | SUNGLASSES | July 14, 1997 |