Cleared Traditional

K230825 - Smileyscope System (Therapy Mode)

K230825 is an FDA 510(k) clearance for Smileyscope System (Therapy Mode), manufactured by Smileyscope Holding, Inc.. The device is a Class 2 Physical Medicine device with product code QRA cleared through the Traditional 510(k) pathway after a 185-day FDA review.

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

FDA 510(k) Submission Details - K230825

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.

QRA Device Classification - Class 2, Special Controls

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.