510(k) · Cleared
ClearedSmileyscope System (Therapy Mode)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smileyscope Holding, Inc. · QRA Virtual Reality Behavioral Therapy Device For Pain Relief
Cleared on Sep 25, 2023 as substantially equivalent to DEN210014 (Appliedvr, Inc., 2021) after a 185-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Sep 25, 2023
- Review
- 185 days
- Class
- Class II
- Product code
- QRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN210014 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN210014 EaseVRxAppliedvr, Inc. · 2021
- This deviceK230825 Smileyscope System (Therapy Mode)Smileyscope Holding, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN210014 | EaseVRx | Appliedvr, Inc. | 2021 | — |
| 0 (this device) | K230825 | Smileyscope System (Therapy Mode) | Smileyscope Holding, Inc. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QRA device
- #1 K243417 RelieVRxscore 11.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN210014 | EaseVRxSummary page 4…Therapy Device For Pain Relief) Class: II Product Codes: QRA Predicate Device: EaseVRx (AppliedVR Inc), DEN210014 1 Device Description:… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN210014.
How does its category compare?
All QRA devicesQRA Virtual Reality Behavioral Therapy Device For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRA
Too few QRA 510(k)s in any year since 2007 to give a median.
Recalls per year · QRA
No recall names QRA since 2007.
Adverse event reports per year · QRA
No MAUDE report names QRA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Smileyscope System's Therapy Mode is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on guided relaxation and other evidence-based behavioral methods for patients aged 4-11 years who can cooperate and interact with the device at a developmentally appropriate level. The Smileyscope Therapy Mode is intended to temporarily reduce and/or manage pain and temporarily relieve acute procedural anxiety associated with needle procedures (e.g., venipuncture, IV placement, vaccination, port access, subcutaneous injections). The device is not intended to treat anxiety disorders or specific phobias (e.g. trypanophobia).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230825 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230825: Smileyscope System (Therapy Mode).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230825
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026