QMMClass II
Hydrophilic Re-coating Solution
Ophthalmic · 21 CFR 886.5919
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.
MDR events1All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances1All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
1 clearances for this product code