Intraocular Pressure Lowering Implant

OGO · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: OGO
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: OP
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 10

Source

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