Not Cleared Direct

DEN200002 - Tangible Boost (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200002 · Tangible Science, Inc. · Ophthalmic device
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Sep 2020
Decision
255d
Days
Class 2
Risk

DEN200002 is an FDA 510(k) submission (not cleared) for the Tangible Boost. Classified as Hydrophilic Re-coating Solution (product code QMM), Class II - Special Controls.

Submitted by Tangible Science, Inc. (Redwood City, US). The FDA issued a Not Cleared (DENG) decision on September 24, 2020 after a review of 255 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5919 - the FDA ophthalmic device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 255 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Tangible Science, Inc. devices

Submission Details

510(k) Number DEN200002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 13, 2020
Decision Date September 24, 2020
Days to Decision 255 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 110d · This submission: 255d
Pathway characteristics

Device Classification

Product Code QMM Hydrophilic Re-coating Solution
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5919
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.