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Short answer: “Alger brush” is a trade name. In FDA’s regulations the generic device is a powered corneal burr, a battery- or AC-powered motor and drilling tool intended to remove rust rings from the cornea. It is Class I (general controls), exempt from premarket notification, and carries FDA product code OHW. General information only; this page is not medical advice and does not describe how to use the device on a patient.
Definition and scope
Under 21 CFR 886.4070, 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 (eCFR, checked 2026-10-31). The Alger Co Inc sells instruments under the ALGERBRUSH name, and FDA’s database lists such products under the generic description “burr, corneal, battery powered, rust ring removal”. So “Alger brush”, “corneal burr” and “powered corneal burr” are overlapping names for one regulatory device type, and “eye spud” names a different, manual instrument (see the comparison below).
This page covers identity, classification and records. It does not cover clinical technique, and it gives no prices, stock or product recommendations.
How it is described in practice
The regulation states one intended use: removing rust rings from the cornea, using a motor-driven drilling tool. FDA’s classification entry for product code OHW (page dated 10/26/2026, checked 2026-10-31) records the device as Class 1, 510(k) exempt, in the Ophthalmic review panel, not implanted, and eligible for summary malfunction reporting. The 510(k) exemption is subject to the limitations in 21 CFR 886.9.
A specific product’s own instructions for use, not this page, govern handling, cleaning and sterilization. For example, the NLM AccessGUDID record for ALGERBRUSH II 1mm Complete Instrument, Carbide Burr (checked 2026-10-31) lists the company as The Alger Co Inc, product code OHW, not packaged sterile, sterilization required before use (dry heat), and not single-use. Those flags belong to that record; other records for burrs and handpieces can differ.
Powered corneal burr vs manual eye spud and manual corneal burr
FDA regulates the powered and manual instruments in separate sections. Each row below comes from the cited regulation or FDA entry.
| Item | Powered corneal burr | Manual ophthalmic surgical instrument |
|---|---|---|
| Regulation | 21 CFR 886.4070 | 21 CFR 886.4350 |
| Power | AC- or battery-powered motor and drilling tool | Nonpowered, handheld |
| Devices named in the section | Powered corneal burr (intended to remove rust rings from the cornea) | Includes the “manual corneal burr” and the “ophthalmic spud”, among many other ophthalmic instruments |
| Classification | Class I (general controls), exempt from premarket notification, subject to 886.9 limitations | Class I (general controls); the section states the device is exempt from premarket notification |
| Product code example | OHW (battery powered, rust ring removal) | See the ophthalmic surgical instruments guide for the manual types and their codes |
The 886.4350 identification is a broad list of generic types, so naming a manual instrument as a “spud” or “burr” in a catalogue does not by itself say which FDA record it belongs to. The related trephine guide covers how FDA classifies that separate cutting device.
Where it matters for labs, clinics and supply records
Because the name is a brand while the regulation uses a generic term, a purchasing or inventory record may be filed under any of several names. A neutral records checklist, built only from the fields the sources above publish:
- Generic name and code: match the item to the FDA description (powered corneal burr, OHW) rather than to the trade name alone.
- Company: confirm the labeler named on the GUDID record.
- Sterility flags: read “packaged sterile” and “requires sterilization prior to use” on the specific record; the listed method for the example above is dry heat.
- Single-use flag: read it per record; the example above is marked not single-use.
- Instructions for use: reprocessing and handling follow the manufacturer’s IFU for that model.
- Identifiers: device identifiers on labels follow UDI rules; see UDI-PI vs the UDI-DI.
Other FDA classification pages that follow the same pattern (class, product code, exemption) include dental pliers.
Common misunderstandings
“Alger brush” is a product category
It is a brand name used for a device type. FDA’s term is powered corneal burr.
Class I exempt means no rules apply
Class I devices remain subject to general controls, and the 510(k) exemption is stated in 886.4070 as subject to the limitations in 886.9. FDA lists OHW as eligible for summary malfunction reporting.
An eye spud and a corneal burr are the same
Regulation 886.4350 lists the “manual corneal burr” and the “ophthalmic spud” as separate manual instrument types, while the powered burr sits in 886.4070.
All burrs are sterile single-use or all are reusable
Neither. The sterility and single-use fields are set record by record in GUDID.
FAQ
What is an Alger brush?
A brand name for a battery-powered corneal burr, a device FDA defines as a motor and drilling tool intended to remove rust rings from the cornea (21 CFR 886.4070).
What is the FDA class and product code?
Class I (general controls), 510(k) exempt subject to 886.9, product code OHW, Ophthalmic review panel (FDA classification database, checked 2026-10-31).
Is a corneal burr the same as an eye spud?
No. A powered corneal burr is covered by 886.4070; the ophthalmic spud and the manual corneal burr are listed in 886.4350 as nonpowered, handheld instruments.
Is it sterile and single-use?
It depends on the specific product. The ALGERBRUSH II 1mm record in AccessGUDID lists it as not packaged sterile, requiring sterilization before use (dry heat), and not single-use; check each record and its IFU.
Sources
- 21 CFR 886.4070, Powered corneal burr, eCFR, checked 2026-10-31 (https://www.ecfr.gov/current/title-21/part-886/section-886.4070).
- 21 CFR 886.4350, Manual ophthalmic surgical instrument, eCFR, checked 2026-10-31 (https://www.ecfr.gov/current/title-21/part-886/section-886.4350).
- FDA Product Classification, code OHW, checked 2026-10-31 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=OHW).
- NLM AccessGUDID, ALGERBRUSH II, device identifier 00860005369201, checked 2026-10-31 (https://accessgudid.nlm.nih.gov/devices/00860005369201).
