# K202361: UltraSlim Digital, UltraSmooth Digital

- Pathway: 510(k) (Traditional)
- Applicant: Ward Photonics, LLC
- Decided: Dec 18, 2020 after 121 days
- Product code: OLI (Fat Reducing Low Level Laser)
- Device class: 2
- Regulation: 21 CFR 878.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943450 (1995). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160880: Photonica Professional, Ward Photonics, LLC (2016) Summary page 4.
- K150336: Photonica Professional, Ward Photonics, LLC (2015) Summary page 4.
- K180338: Cellulize, Ward Photonics, LLC (2018) Summary page 4.

## Indications for use
UltraSlim DIGITAL is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. UltraSlim DIGITAL is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions. UltraSmooth DIGITAL is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The Massager component is indicated for the temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K202361
Methodology: https://510kreport.com/methodology