Burr, Corneal, Battery Powered, Rust Ring Removal

OHW · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.4070

Classification

FDA Product Code: OHW
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 886.4070
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 19

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown