510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OHWClass I

Burr, Corneal, Battery Powered, Rust Ring Removal

21 CFR 886.4070 / Ophthalmic
FDA source (opens on fda.gov)

OHW is the FDA product code for Burr, Corneal, Battery Powered, Rust Ring Removal, a class I device type, regulated under 21 CFR 886.4070. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
OHW
Device name
Burr, Corneal, Battery Powered, Rust Ring Removal
FDA 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.
Regulation
21 CFR 886.4070
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order