510(k) · Cleared
ClearedmiraDry System
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 15, 2018 as substantially equivalent to K160141 (Miramar Labs, Inc., 2016) after a 30-day review. Its family tree reaches back 12 generations to 1986.
- Decided
- Mar 15, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K861904 (1986). 25 ancestors in all, the oldest K790187 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 8 generations between
- 3 generations backK131162 Miradry SystemMiramar Labs, Inc. · 2013 · Recalled
- 2 generations backK150419 miraDry System MD4000Miramar Labs, Inc. · 2015 · Recalled
- 1 generation backK160141 miraDry SystemMiramar Labs, Inc. · 2016
- This deviceK180396 miraDry SystemMiramar Labs, Inc. · 2018
Show all 12 generations
- Root · 12 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 11 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 10 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 9 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 8 generations backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 7 generations backK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
- 6 generations backK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
- 5 generations backK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
- 4 generations backK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled
- 3 generations backK131162 Miradry SystemMiramar Labs, Inc. · 2013 · Recalled
- 2 generations backK150419 miraDry System MD4000Miramar Labs, Inc. · 2015 · Recalled
- 1 generation backK160141 miraDry SystemMiramar Labs, Inc. · 2016
- This deviceK180396 miraDry SystemMiramar Labs, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −11 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −10 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −9 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −8 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −7 | K052919 | Microsulis Tissue Ablation System | Microsulis Americas, Inc. | 2006 | — |
| −6 | K072870 | Microwave Tissue Coagulation System (MTCS) | Foundry Newco X, Inc. | 2008 | — |
| −5 | K082819 | Dermatologic Treatment System (DTS) G2 | Miramar Labs, Inc. | 2009 | — |
| −4 | K103014 | Miradry System | Miramar Labs, Inc. | 2011 | 2 |
| −3 | K131162 | Miradry System | Miramar Labs, Inc. | 2013 | 1 |
| −2 | K150419 | miraDry System MD4000 | Miramar Labs, Inc. | 2015 | 1 |
| −1 | K160141 | miraDry System | Miramar Labs, Inc. | 2016 | — |
| 0 (this device) | K180396 | miraDry System | Miramar Labs, Inc. | 2018 | — |
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 |
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 |
|---|---|---|---|
| * | K160141 | miraDry SystemSummary page 4…d Accessories System, Microwave, Hair Removal Trade Name miraDry MD4000 System Predicate Device miraDry MD 4000 System K160141 Submitter: Miramar Labs, Inc. 2790 Walsh Avenue Santa Clara,… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 25 ancestors have a recall of any class.
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. 2018, 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 miraDry System MD4000 is indicated for use in the treatment of primary axillary hyperhidrosis plus unwanted underarm hair removal, and permanent reduction of underarm hair of all colors for Fitzpatrick skin types I – IV.
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
When used with the treatment of primary axillary hyperhidrosis, the miraDry System may reduce underarm odor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180396: miraDry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180396
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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