Product code QMM

Device name

Hydrophilic Re-Coating Solution

Medical specialty

Ophthalmic

Device class

2

Regulation number

886.5919

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset