510(k) · Cleared
ClearedDermatologic Treatment System (DTS) G2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miramar Labs, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Mar 20, 2009 as substantially equivalent to K072870 (Foundry Newco X, Inc., 2008) after a 176-day review. Its family tree reaches back 7 generations to 1986. 10 later devices descend from it.
- Decided
- Mar 20, 2009
- Review
- 176 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K861904 (1986). 20 ancestors in all, the oldest K790187 (1979). 10 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 6 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 5 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 4 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 3 generations backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 2 generations backK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
- 1 generation backK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
- This deviceK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled
- Descendant · cites it directly · 3 of its ownK181941 Swift SystemEmblation, Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK131162 Miradry SystemMiramar Labs, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK222388 swiftPro SystemEmblation, Ltd. · 2023
- Descendant · 3 generations on · 2 of its ownK150419 miraDry System MD4000Miramar Labs, Inc. · 2015 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K103014Miradry SystemMiramar Labs, Inc. · 2011 · cites it directly5descendants
- K181941Swift SystemEmblation, Ltd. · 2018 · cites it directly3descendants
- K131162Miradry SystemMiramar Labs, Inc. · 2013 · 2 generations on3descendants
- K222388swiftPro SystemEmblation, Ltd. · 2023 · 2 generations on2descendants
- K150419miraDry System MD4000Miramar Labs, Inc. · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −6 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −5 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −4 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −3 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −2 | K052919 | Microsulis Tissue Ablation System | Microsulis Americas, Inc. | 2006 | — |
| −1 | K072870 | Microwave Tissue Coagulation System (MTCS) | Foundry Newco X, Inc. | 2008 | — |
| 0 (this device) | K082819 | Dermatologic Treatment System (DTS) G2 | Miramar Labs, Inc. | 2009 | — |
| +1 | K103014 | Miradry System | Miramar Labs, Inc. | 2011 | 2 |
| +1 | K181941 | Swift System | Emblation, Ltd. | 2018 | — |
| +2 | K131162 | Miradry System | Miramar Labs, Inc. | 2013 | 1 |
| +2 | K222388 | swiftPro System | Emblation, Ltd. | 2023 | — |
| +3 | K150419 | miraDry System MD4000 | Miramar Labs, Inc. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NEY device
- #1 K253771 Disposable Microwave Ablation Antenna…score 14.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072870 | Microwave Tissue Coagulation System (MTCS)Summary page 1…VP, Clinical and Regulatory Affairs Intended Use The DTS G2 System is indicated for use for coagulation of soft tissue. Predicate Devices K072870 Foundry Newco X Microwave Tissue Coagulation System Device Description The DTS G2 System is designed to intera… | 2008 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K103014 (Miramar Labs, Inc., 2011) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K072870.
How does its category compare?
All NEY devicesNEY System, Ablation, Microwave And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NEY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEY
94in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEY
112in 2025
MAUDE reports naming product code NEY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 18 |
| 2008 | 3 | 145 | 0 | 15 |
| 2009 | 4 | 169 | 0 | 7 |
| 2010 | 3 | 219 | 0 | 28 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 3 | 81 | 0 | 9 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 92 |
| 2016 | 3 | 30 | 0 | 176 |
| 2017 | 3 | 121 | 12 | 225 |
| 2018 | 3 | 90 | 3 | 102 |
| 2019 | 2 | — | 0 | 123 |
| 2020 | 7 | 178 | 0 | 128 |
| 2021 | 4 | 379 | 1 | 217 |
| 2022 | 1 | — | 1 | 142 |
| 2023 | 9 | 155 | 0 | 106 |
| 2024 | 7 | 94 | 0 | 141 |
| 2025 | 1 | — | 0 | 112 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The DTS G2 System is indicated for use for coagulation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082819: Dermatologic Treatment System (DTS) G2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082819
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026