Burr, Corneal, Battery Powered, Rust Ring Removal

Who Makes This Device Type in China?

4 manufacturers in China hold an FDA registration for this device type, based in Guangdong. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Huizhou Foryou Medical Devices Co., Ltd. Guangdong, contract manufacturer
Shenzhen Create Technology Co., Ltd. Guangdong
Shenzhen JPY ION-Tech. Co., Ltd. Guangdong, contract manufacturer
Shenzhen Jie Zhong Lian Technology Co., Ltd. Guangdong, contract manufacturer

What Is It?

A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.

How Is OHW Classified?

Burr, Corneal, Battery Powered, Rust Ring Removal is FDA product code OHW, Class 1, 21 CFR 886.4070.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2016. None was by a company in China. The root cause the FDA records most often is Error in labeling (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Burr, Corneal, Battery Powered, Rust Ring Removal

Algerbrush Corn Rust Ring REM Burr 1.0MM

Catalogue number AE-3252, listed by Katena Products, Inc., United States, under Burr, Corneal, Battery Powered, Rust Ring Removal. 4 manufacturers in China are registered for this product code.

Burr, Corneal, Battery Powered, Rust Ring Removal

Algerbrush Rust Ring REM Burr 0.5MM

Catalogue number AE-3251, listed by Katena Products, Inc., United States, under Burr, Corneal, Battery Powered, Rust Ring Removal. 4 manufacturers in China are registered for this product code.

Burr, Corneal, Battery Powered, Rust Ring Removal

Algerbrush II Corneal Rust Ring Remover

Algerbrush II Corneal Rust Ring Remover 0.5 Millimeter Burr Battery Powered Complete SET

Burr, Corneal, Battery Powered, Rust Ring Removal

Yoshida Diamond Coated Burr

Catalogue number AE-3254, listed by Katena Products, Inc., United States, under Burr, Corneal, Battery Powered, Rust Ring Removal. 4 manufacturers in China are registered for this product code.

Burr, Corneal, Battery Powered, Rust Ring Removal

Algerbrush II Pterygium 3.5 RND MED Diam

Catalogue number AE-3260, listed by Katena Products, Inc., United States, under Burr, Corneal, Battery Powered, Rust Ring Removal. 4 manufacturers in China are registered for this product code.

Burr, Corneal, Battery Powered, Rust Ring Removal

Algerbrush Rust Ring REM CHUCK.5MM Burr

Catalogue number AE-3255, listed by Katena Products, Inc., United States, under Burr, Corneal, Battery Powered, Rust Ring Removal. 4 manufacturers in China are registered for this product code.

Burr, Corneal, Battery Powered, Rust Ring Removal

Algerbrush Burr

Algerbrush II Pterygium Burr Medium Wheel

Burr, Corneal, Battery Powered, Rust Ring Removal

Wexler Surgical, Inc.

6 catalogue numbers from BL0002.4-1, listed by Wexler Surgical, Inc., United States, under Burr, Corneal, Battery Powered, Rust Ring Removal. 4 manufacturers in China are registered for this product code.

Burr, Corneal, Battery Powered, Rust Ring Removal

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…

Burr, Corneal, Battery Powered, Rust Ring Removal

Algerbrush II

ALGERBRUSH II .5mm Complete Instrument, Carbide Burr

Burr, Corneal, Battery Powered, Rust Ring Removal

MSI Precision Specialty Instruments

Algerbrush 2 Pteryguim, Battery Operated, Single Speed, Motorized Handpiece, Tip Cover, 5mm Tip, Wheel Shaped Diamond Burr, Medium Grit, One "AA" Battery, Overall Length 4-1/8" (105mm)

Burr, Corneal, Battery Powered, Rust Ring Removal

Algerbrush Corn Rust Ring REM 0.5MM Burr

Catalogue number AE-3250, listed by Katena Products, Inc., United States, under Burr, Corneal, Battery Powered, Rust Ring Removal. 4 manufacturers in China are registered for this product code.

Burr, Corneal, Battery Powered, Rust Ring Removal

Algerbrush Diamond Burr

Algerbrush Diamond Burr Medium Grit Complete With Handle Pterygium

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer