QMM · Class II · 21 CFR 886.5919

FDA Product Code QMM: Hydrophilic Re-coating Solution

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.

Leading manufacturers include Tangible Science, Inc..

1
Total
0
Cleared
255d
Avg days
2020
Since

FDA 510(k) Cleared Hydrophilic Re-coating Solution Devices (Product Code QMM)

1 devices
1–1 of 1
Not Cleared Sep 24, 2020
Tangible Boost
DEN200002
Tangible Science, Inc.
Ophthalmic · 255d

About Product Code QMM - Regulatory Context