QMM

Hydrophilic Re-Coating Solution

Product code

QMM

Device name

Hydrophilic Re-Coating Solution

Device class

Class 2

21 CFR

21 CFR 886.5919

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).