# K230825: Smileyscope System (Therapy Mode)

- Pathway: 510(k) (Traditional)
- Applicant: Smileyscope Holding, Inc.
- Decided: Sep 25, 2023 after 185 days
- Product code: QRA (Virtual Reality Behavioral Therapy Device For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 890.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN210014 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN210014: EaseVRx, Appliedvr, Inc. (2021) Summary page 4.

## Indications for use
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).

Source page: https://510kreport.com/device/K230825
Methodology: https://510kreport.com/methodology