FDA Device Registration & Listing · Montreal Quebec, CA · Registration 3006297986
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | Class 1 | 886.5850 | 2008-05-22 |
| LPM | Lenses, Soft Contact, Extended Wear | Ophthalmic | Class 3 | 886.5925 | 2010-08-13 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-11-23 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2017-11-23 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2017-09-02 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-09-02 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2026-04-19 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2017-01-26 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-01-26 |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | Class 1 | 886.5850 | 2016-08-05 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2015-10-16 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2012-05-24 |
| HQZ | Frame, Spectacle | Ophthalmic | Class 1 | 886.5842 | 2018-01-03 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-09-02 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2017-09-02 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2016-03-25 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-03-25 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2019-06-27 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2019-06-27 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-01-26 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2017-05-05 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-05-05 |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | Class 1 | 886.5850 | 2016-06-14 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K940726 | Jay-Y Enterprises Co., Inc. | NONE-GENERIC | 1994-04-11 |
| K934837 | Simon Marketing, Inc. | SUNGLASSES | 1993-12-08 |
| K852902 | Yours Enterprise Co., Ltd. | METALLIC SUNGLASSES | 1985-08-12 |
| K970895 | Custom Optical Frames, Inc. | CUSTOM OPTICAL SUNGLASS FRAMES | 1997-05-06 |
| K853921 | Winsburn Company , Ltd. | ALL KINDS OF SUNGLASSES | 1985-10-15 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0018-07 | Ciba Vision Corporation | 2 | CSI Daily Wear, soft (hydrophilic) contact lenses |
| Z-0019-07 | Ciba Vision Corporation | 2 | CSI Flexible Wear, soft (hydrophilic) contact lenses |
| Z-0020-07 | Ciba Vision Corporation | 2 | CSI Toric, soft (hydrophilic) contact lenses |
| Z-0044-2012 | CooperVision Inc. | 2 | AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736.
Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system. |
| Z-0326-2026 | Alcon Research LLC | 2 | Alcon PRECISION1 One-Day Contact Lenses, -2.25D. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007009595 | RAEN OPTICS | Oceanside, CA, US |
| 3008137594 | CHLOE SAS | PARIS Ile-de-France, FR |
| 3042870833 | GOLEADER(VIETNAM) RECREATION LIMITED | Tan Phuoc 3 Commune Dong Thap, VN |
| 3009141079 | STAGE | Sandy, UT, US |
| 3013857947 | FARFETCH ITALIA S.R.L. | MILAN Milano, IT |
3006297986 when referencing this establishment in official correspondence.