LASIK Caro-Avalos Flap Smoother
Catalogue number 8080, listed by Katalyst Surgical, LLC, United States, under Hook, Ophthalmic. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Ophsurin Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 6 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Katalyst Surgical, LLC, United States |
|---|---|
| FDA product code | HNQ |
| Device type | Hook, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-20 |
| Record revised | 2023-03-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8080 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Walcott Rx Products | Walcott Rx Product Inc | 511 |
| Ambler Surgical | Ambler Surgical, LLC | 416 |
| MR Phaco | Crestpoint Management Ltd. | 403 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 385 |
| Millennium | Avalign Technologies, Inc. | 244 |
| Stephens Instruments | Krishna Imports Inc | 98 |
| Diamatrix | Diamatrix | 89 |
| Duckworth & Kent | Duckworth AND Kent Limited | 85 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 81 |
| Rumex | Rumex International Co. | 77 |
| Ophthalmic Hook | Katena Products, Inc. | 74 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 74 |
Showing 12 of 534. All products under Hook, Ophthalmic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.