510(k) DEN200002
DEN200002 is an FDA 510(k) premarket notification submitted by Tangible Science, Inc. for the device "Tangible Boost". The FDA issued a decision of De Novo Granted on September 24, 2020. The device falls under product code QMM (Hydrophilic Re-Coating Solution), a Class II device regulated under 21 CFR 886.5919. Tangible Science, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 24, 2020
- Date Received
- January 13, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hydrophilic Re-Coating Solution
- Device Class
- Class II
- Regulation Number
- 886.5919
- Review Panel
- OP
- Submission Type
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.