# K082819: Dermatologic Treatment System (DTS) G2

- Pathway: 510(k) (Traditional)
- Applicant: Miramar Labs, Inc.
- Decided: Mar 20, 2009 after 176 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K861904 (1986). 20 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072870: Microwave Tissue Coagulation System (MTCS), Foundry Newco X, Inc. (2008) Summary page 1.

## Most influential descendants
- K103014: Miradry System (2011), 5 descendants of its own
- K181941: Swift System (2018), 3 descendants of its own
- K131162: Miradry System (2013), 3 descendants of its own
- K222388: swiftPro System (2023), 2 descendants of its own
- K150419: miraDry System MD4000 (2015), 2 descendants of its own

## Indications for use
The DTS G2 System is indicated for use for coagulation of soft tissue.

Source page: https://510kreport.com/device/K082819
Methodology: https://510kreport.com/methodology