FDA Device Registration & Listing · Kecskemet Bacs-Kiskun, HU · Registration 3002296055
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2024-02-01 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2024-02-01 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2018-08-27 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2018-08-27 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2024-04-04 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2024-04-04 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2019-08-01 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2019-08-01 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| QIT | Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia | Unknown | Class 3 | N/A | 2026-06-17 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| LPM | Lenses, Soft Contact, Extended Wear | Ophthalmic | Class 3 | 886.5925 | 2016-03-08 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| LPM | Lenses, Soft Contact, Extended Wear | Ophthalmic | Class 3 | 886.5925 | 2016-03-08 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2024-11-19 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2024-11-19 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2020-12-02 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2021-06-25 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2018-07-24 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-03-08 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K133079 | Alden Optical Labs., Inc. | IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) | 2013-12-17 |
| K941998 | Ocu-Ease Optical Products, Inc. | OCU-FLEX-38 (POLYMACON) | 1994-10-13 |
| K992500 | Cantor & Silver , Ltd. | CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS | 1999-08-18 |
| K984098 | Adventures IN Color Technology, Ltd. | ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS | 1999-05-10 |
| K003161 | Les Laboratoires Blanchard | ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT | 2000-12-15 |
| 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 |
|---|---|---|
| 3013785060 | CAMDEN PASSAGE | Collingwood Ontario, CA |
| 3008585940 | GEO MEDICAL CO., LTD | Buk-gu Gwangju, KR |
| 3005994941 | SOLOTICA INDUSTRIA E COMERCIO LTDA | Sao Paulo, BR |
| 3012590738 | EYEYON MEDICAL | Nes Ziona Central, IL |
| 3025414414 | SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD. | Shenzhen Guangdong, CN |
3002296055 when referencing this establishment in official correspondence.