DeviceClearance

Product code QMM— Ophthalmic

Tangible Boost

Classification name
Hydrophilic Re-Coating Solution
Device class
Class 2
Regulation
21 CFR 886.5919
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QMM under 21 CFR 886.5919, via openFDA

Market context for product code QMM

FDA has cleared 1 device under product code QMM, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QMM

Recent clearances under product code QMM

Data sourced from openFDA. This site is unofficial and independent of the FDA.