Product code HQG
- Device name
- Lens, Spectacle, Non-Custom (Prescription)
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.5844
- 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 |
|---|---|---|---|
| K935919 | SUNGLASSES | Ja-Ru, Inc. | 1994-02-16 |
| K920795 | 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX | Optical Radiation Corp. | 1992-07-13 |
| K900091 | MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR | Onufryk Low Vision Ent. | 1990-04-04 |
| K884360 | SEIKO P-6 PROGRESSIVE SPECTACLE LENSES | Seiko Corp. | 1988-11-15 |
| K882814 | NEOLENS PRESCRIPTION SPECTACLE LENS | Neolens, Inc. | 1988-07-29 |
| K882308 | CR-39 PLASTIC LENSES FOR EYEGLASSES | Automated Lens System | 1988-07-22 |
| K881225 | OPHTHALMIC SPECTACLE LENS BLANKS | Beta Optical Co, Inc. | 1988-04-19 |
| K875063 | SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. | Epson EL Paso, Inc. | 1988-02-22 |
| K874681 | SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES | Klockner Contract Packaging, Inc. | 1988-02-05 |
| K873245 | AR DIACOAT SINGLE VISION LENSES | Seiko Optical Products of America, Inc. | 1987-10-05 |
| K872506 | MELANITE I | Aura Lens Products | 1987-07-27 |
| K871961 | MULTIPLE SPECTACLE LENS | Korea Asahi Optical Co., Ltd. | 1987-06-03 |
| K865103 | KROM-X LENS SYSTEM | Neo Optics, Inc. | 1987-01-20 |
| K863367 | FORMALENS 2000 | Vision-Sciences, Inc. | 1986-09-26 |
| K862578 | TECHNA VISION CASTING RESIN | Techna Vision | 1986-07-23 |
| K861021 | GOTTEX SUNGLASSES | Private Eyes Sunglass Corp. | 1986-06-17 |
| K861960 | ZIMLITE LENS | Asahi Optical Co. C/O Rosati Associates, P.C. | 1986-06-09 |
| K861759 | GIRARD SUNGLASSES (NON-PRESCRIPTION) | H. Girard S.A. | 1986-06-09 |
| K861684 | SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) | Seiko Optical Products of America, Inc. | 1986-06-09 |
| K861162 | LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) | Efop | 1986-06-09 |
| K860794 | WRAPPERS, SUNGLASSES | Mhci Corp. | 1986-04-21 |
| K860955 | SPECTACLES LENS | Roseburg SA | 1986-03-31 |
| K854218 | THE ULTRA-MATE LENS | Optical Systems Intl., Inc. | 1985-11-12 |
| K851410 | O.M.S. UV-COLOURS | Optical Moulding Systems | 1985-08-27 |
| K852403 | AURALITE II | Aura Lens Products | 1985-08-20 |
| K853110 | SPECTACLE PRESCRIPTION LENSES | Ancie Laboratories | 1985-08-09 |
| K851163 | SUNGLASES | Full See Glasses Ind. Co., Ltd. | 1985-05-30 |
| K850905 | CR-39 TYPE RESIN | Orplex Corp. | 1985-03-20 |
| K844778 | SUNGLASSES | B & M Sporting Goods, Inc. | 1985-01-04 |
| K842189 | MULTIPLE LENS, SPECTACLES CUSTOM | Hanmy Optical Industrial Co. | 1984-12-11 |
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| 00648478821279 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00648478821262 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00648478821255 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00648478821248 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00648478821231 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00648478821224 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00648478821217 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00648478821200 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00648478821194 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00648478821187 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00648478821170 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00648478821163 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917347673 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917345945 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917345914 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917340308 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917340292 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917340278 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917340261 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917340247 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917339791 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917339777 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917321857 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917321840 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917321703 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 00054917321697 | Bollé Brands | BOLLE BRANDS (FRANCE) | 2025-09-25 |
| 04064495039415 | ZEISS Optical Inserts | Carl Zeiss Vision International GmbH | 2023-12-20 |
| 16974852470070 | Spectacle Lens | Luxin Optical (Shanghai) Co., Ltd. | 2023-03-09 |
| 08012794011478 | BOLT&ARROW | LA GIARDINIERA SRL | 2023-01-24 |