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QMMClass II

Hydrophilic Re-Coating Solution

21 CFR 886.5919 / Ophthalmic
FDA source (opens on fda.gov)

QMM is the FDA product code for Hydrophilic Re-Coating Solution, a class II device type, regulated under 21 CFR 886.5919. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QMM
Device name
Hydrophilic Re-Coating Solution
FDA 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.
Regulation
21 CFR 886.5919
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QMM

By decision year
1 clearance under product code QMM with a decision year between 2020 and 2020, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QMM by decision year
YearClearances
20201

Applicants with the most clearances

Product code QMM
Applicants holding the most 510(k) clearances under product code QMM
ApplicantClearances
TANGIBLE SCIENCE Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code