Cleared Traditional

K230825 - Smileyscope System (Therapy Mode) (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230825 · Smileyscope Holding, Inc. · Physical Medicine device
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Sep 2023
Decision
185d
Days
Class 2
Risk

K230825 is an FDA 510(k) clearance for the Smileyscope System (Therapy Mode). Classified as Virtual Reality Behavioral Therapy Device For Pain Relief (product code QRA), Class II - Special Controls.

Submitted by Smileyscope Holding, Inc. (Austin, US). The FDA issued a Cleared decision on September 25, 2023 after a review of 185 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5800 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Smileyscope Holding, Inc. devices

Submission Details

510(k) Number K230825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2023
Decision Date September 25, 2023
Days to Decision 185 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 115d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QRA Virtual Reality Behavioral Therapy Device For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5800
Definition A Virtual Reality Behavioral Therapy Device For Pain Relief Is A Device Intended To Provide Behavioral Therapy For Patients With Pain. Therapy Is Administered Via A Virtual Reality Display Which Utilizes A Software Program Containing The Behavioral Therapy Content.
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 Physical Medicine devices follow this clearance model.