Burr
Algerbrush II is a hand-held, battery-powered ophthalmic burr used by eye-care professionals to remove foreign bodies from the eye. The listed product is the ophthalmic corneal-burr model…
Algerbrush II is a hand-held, battery-powered ophthalmic burr used by eye-care professionals to remove foreign bodies from the eye. The listed product is the ophthalmic corneal-burr model in the Algerbrush family.
The tool uses a low-torque, slow-spin motor. The manufacturer describes its slow, low-torque operation for foreign-body removal on corneal tissue.
Listed Item
Algerbrush II (Ophthalmic Corneal Burr)
Handpiece and Burr
The battery-powered handpiece rotates the burr tip with a slow, low-torque motor for mechanical removal of ocular foreign bodies. The burr is the working end of the instrument.
Algerbrush II is a compact ophthalmic handpiece supplied in configurations with different burr tips. The listed model identifies a corneal burr version within that instrument family.
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Shenzhen Create Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
Record
| Listed by | Katena Products, Inc., United States |
|---|---|
| FDA product code | OHW |
| Device type | Burr, Corneal, Battery Powered, Rust Ring Removal |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-16 |
| Record revised | 2022-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Sizes | Circumference 0.5 to 1 mm; length 0.5 to 1 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08-13142 | Circumference 0.5 mm | In distribution |
| 08-13140 | Circumference 1 mm | In distribution |
| K2-4910 | In distribution | |
| K2-4909 | In distribution | |
| K2-4903 | In distribution | |
| 08-13158 | In distribution | |
| K2-4900 | In distribution | |
| 08-13149 | Length 1 mm | In distribution |
| 08-13148 | Length 0.5 mm | In distribution |
| 08-13141 | Circumference 1 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 25 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 6 |
| Algerbrush Diamond Burr | Sontec Instruments, Inc. | 5 |
| Algerbrush II | THE Alger Company, Inc. | 2 |
| Algerbrush Burr | Sontec Instruments, Inc. | 2 |
| Algerbrush II Corneal Rust Ring Remover | Sontec Instruments, Inc. | 2 |
| Algerbrush Corn Rust Ring REM 0.5MM Burr | Katena Products, Inc. | 1 |
| Algerbrush Rust Ring REM CHUCK.5MM Burr | Katena Products, Inc. | 1 |
| Algerbrush II Pterygium 3.5 RND MED Diam | Katena Products, Inc. | 1 |
| Yoshida Diamond Coated Burr | Katena Products, Inc. | 1 |
| Algerbrush Rust Ring REM Burr 0.5MM | Katena Products, Inc. | 1 |
| Algerbrush Corn Rust Ring REM Burr 1.0MM | Katena Products, Inc. | 1 |
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.