QMM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hydrophilic Re-Coating Solution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5919
- Medical specialty
- Ophthalmic
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Tangible Boost (DEN200002) | Tangible Science, Inc. | 2020-09-24 |
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