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510(k) Data Aggregation
K Number
DEN200002Device Name
Tangible Boost
Manufacturer
Date Cleared
2020-09-24
(255 days)
Product Code
Regulation Number
886.5919Why did this record match?
Applicant Name (Manufacturer) :
Tangible Science, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Tangible Boost is a monthly treatment to restore the Tangible Hydra-PEG coating and maintain the wettability of Tangible Hydra-PEG treated fluorosilicone acrylate rigid gas permeable lenses. Tangible Boost is intended for prescription (Rx) use only.
Device Description
Tangible Boost is a monthly treatment specifically for RGP CLs made from fluorosilicone acrylate and manufactured with a Hydra-PEG coating. Tangible Boost is intended for prescription (Rx) use only, and for home use. Tangible Boost is not intended for lens disinfection and must be used in conjunction with a compatible multipurpose solution, as described in the labeling.
Tangible Boost restores the Tangible Hydra-PEG coating and maintains the wettability of Tangible Hydra-PEG treated fluorosilicone acrylate lenses. The device consists of two sterile, preservative-free, unit dose solutions to be combined in the single use, disposable Tangible Boost barrel style lens case (included in the device packaging). Patients who are allergic to any ingredient (e.g. Tangible Hydra-PEG) should not use this device.
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