FDA Device Registration & Listing · DULUTH, GA, US · Registration 1053053
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 | 2023-01-12 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-11-14 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2017-11-14 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2013-08-13 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2013-08-13 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2019-04-04 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2019-04-04 |
| HPA | Frame, Trial, Ophthalmic | Ophthalmic | Class 1 | 886.1415 | 2021-04-28 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-11-14 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2017-11-14 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2020-07-08 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2020-07-08 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2013-12-10 |
| LPM | Lenses, Soft Contact, Extended Wear | Ophthalmic | Class 3 | 886.5925 | 2023-08-31 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2013-12-10 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-11-14 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2017-11-14 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2021-04-21 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2021-04-21 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2023-01-12 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2023-01-12 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2019-01-09 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2019-01-09 |
| LPM | Lenses, Soft Contact, Extended Wear | Ophthalmic | Class 3 | 886.5925 | 2013-10-30 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-11-14 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2013-12-10 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2024-09-12 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2024-09-12 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2013-12-04 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2013-12-04 |
| HPC | Set, Lens, Trial, Ophthalmic | Ophthalmic | Class 1 | 886.1405 | 2021-04-28 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2013-10-30 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2022-01-04 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2022-01-04 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013497605 | Alcon Research, LLC | Sinking Spring, PA, US |
| 3003701944 | OPTONOL, LTD | NEVE ILAN Central, IL |
| 3016232028 | LUMITHERA, INC. | Fort Worth, TX, US |
| 3006186389 | CIBA VISION JOHOR SDN.BHD., | GELANG PATAH, JOHOR DARUL TAKZIM, MY |
| 3016075957 | IVANTIS, INC. | Irvine, CA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K191650 | Alcon Research, LLC | LEGION System | 2019-11-01 |
| 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 |
| 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-0028-05 | Ciba Vision Corporation | 2 | SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product. |
| Z-0095-2021 | Alcon Research, LLC | 2 | Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries. |
| 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 |
1053053 when referencing this establishment in official correspondence.