510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200002Unknown

Tangible Boost

TANGIBLE SCIENCE Inc, Redwood City CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN200002 is the FDA 510(k) clearance record for Tangible Boost, a class II device, cleared for Tangible Science, Inc. on under FDA product code QMM (Hydrophilic Re-Coating Solution). FDA's definition for product code QMM reads: "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". FDA records list 3 510(k) clearances for Tangible Science, Inc., from to . As of , FDA records show no recalls naming DEN200002.

Clearance record

Decision date
Received
(255 days to decision)
Product code
QMM Hydrophilic Re-Coating Solution
Regulation
21 CFR 886.5919
Device class
Class II
Review panel
Ophthalmic
Applicant
Tangible Science, Inc. 740 Broadway, Redwood City CA
Third party review
No

Clearances, product code QMM

Trailing 12 months

FDA records hold no clearances under product code QMM in the trailing twelve months.

FDA records show no clearances under product code QMM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QMM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260