Phakic Toric Intraocular Lens

QCB · Class III — High Risk (PMA approval required, life-sustaining) · Ophthalmic · 21 CFR 886.3600

Classification

FDA Product Code: QCB
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: 21 CFR 886.3600
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

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