OHW — Burr, Corneal, Battery Powered, Rust Ring Removal Class I
FDA product code OHW covers "Burr, Corneal, Battery Powered, Rust Ring Removal", a Class I medical device regulated under 21 CFR 886.4070. Submissions are reviewed by the Ophthalmic panel.
Classification Details
- Product Code
- OHW
- Device Class
- Class I
- Regulation Number
- 886.4070
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
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.