FDA Device Registration & Listing · GREENVILLE, SC, US · Registration 1032500
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 |
|---|---|---|---|---|---|
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2022-02-15 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | Ophthalmic | Class 2 | 886.5918 | 2022-02-15 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | Ophthalmic | Class 2 | 886.5918 | 2020-06-25 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | Ophthalmic | Class 2 | 886.5918 | 2020-06-20 |
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | Ophthalmic | Class 2 | 886.5928 | 2008-01-10 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | Ophthalmic | Class 2 | 886.5918 | 2023-03-27 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2023-03-27 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2021-07-23 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | Ophthalmic | Class 2 | 886.5918 | 2008-01-10 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2008-05-12 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2017-01-17 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | Ophthalmic | Class 2 | 886.5918 | 2020-06-25 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2023-12-14 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2008-01-10 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2008-01-10 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2008-01-10 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2008-01-10 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2008-01-10 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2008-01-10 |
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | Ophthalmic | Class 2 | 886.5928 | 2010-05-03 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1119279 | Bausch & Lomb Incorporated | CLEARWATER, FL, US |
| 1920664 | Bausch & Lomb Incorporated | Saint Louis, MO, US |
| 3007583964 | TOTAL TITANIUM, INC. | Red Bud, IL, US |
| 1281950 | Bausch & Lomb Incorporated | WILMINGTON, MA, US |
| 1315522 | Bausch & Lomb Incorporated | Lancaster, NY, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K093254 | Abbott Medical Optics, Inc. | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION | 2010-09-15 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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-0129-2011 | Abbott Medical Optics Inc (AMO) | 2 | AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml).
Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day. |
| Z-0130-2011 | Abbott Medical Optics Inc (AMO) | 2 | AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml).
Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear. |
| Z-0030-2022 | Contamac Solutions, Inc. | 2 | Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1643525 | ALLERGAN SALES, LLC | WACO, TX, US |
| 3003306559 | GLOBAL PACKAGING SYSTEMS INC | Fort Worth, TX, US |
| 3012236936 | Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, US |
| 9617489 | TAIWAN BIOTECH CO., LTD. | TAOYUAN, TW |
| 3003093882 | NIAGARA PHARMACEUTICALS, INC. | Dundas Ontario, CA |
1032500 when referencing this establishment in official correspondence.