Hydrophilic Re-Coating Solution

QMM · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.5919

Classification

FDA Product Code: QMM
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 886.5919
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components. For prescription use only.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

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