# K202112: Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Storz Medical AG
- Decided: Feb 21, 2021 after 206 days
- Product code: PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers)
- Device class: 2
- Regulation: 21 CFR 878.4685
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN160037 (2017). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160037: dermaPACE System, Sanuwave, Inc. (2017) Summary page 4.
- K191961: OrthoGold, Tissue Regeneration Technologies (2019) Summary page 4.

## Most influential descendants
- K243279: DOLORCLAST Focused Shock Waves (2025), 0 descendants of its own

## Indications for use
The DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The DUOLITH SD1 with C-ACTOR is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

Source page: https://510kreport.com/device/K202112
Methodology: https://510kreport.com/methodology