# K250224: handLITE (TN19S)

- Pathway: 510(k) (Traditional)
- Applicant: iSMART Developments, Ltd.
- Decided: Apr 18, 2025 after 81 days
- Product code: ONE (Powered Light Based Non-Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 97 ancestors in all.
No later device cites it as a predicate yet.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171055: Philips BlueControl, Philips Electronics Nederland B.V. (2017) Summary page 5.
- K191629: faceLITE, Ismart Marketing Svcs, Ltd. (2019) Summary page 5.

## Indications for use
The handLITE is intended to emit energy in the red and near infrared region of the light spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat contact dermatitis of the hand and wrist.

Source page: https://510kreport.com/device/K250224
Methodology: https://510kreport.com/methodology