# DEN200002: Tangible Boost

- Pathway: De Novo (Direct)
- Applicant: Tangible Science, Inc.
- Decided: Sep 24, 2020 after 255 days
- Product code: QMM (Hydrophilic Re-Coating Solution)
- Device class: 2
- Regulation: 21 CFR 886.5919
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for 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.

Source page: https://510kreport.com/device/DEN200002
Methodology: https://510kreport.com/methodology