510(k) · Cleared
Recalled · Class II · 2015miraDry System MD4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miramar Labs, Inc. · OUB Instrument For Treatment Of Hyperhidrosis
Cleared on Jun 19, 2015 as substantially equivalent to K131162 (Miramar Labs, Inc., 2013) after a 121-day review. Its family tree reaches back 10 generations to 1986. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 19, 2015
- Review
- 121 days
- Class
- Class II
- Product code
- OUB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K861904 (1986). 23 ancestors in all, the oldest K790187 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 6 generations between
- 3 generations backK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
- 2 generations backK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled
- 1 generation backK131162 Miradry SystemMiramar Labs, Inc. · 2013 · Recalled
- This deviceK150419 miraDry System MD4000Miramar Labs, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK160141 miraDry SystemMiramar Labs, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK180396 miraDry SystemMiramar Labs, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 9 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 8 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 7 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 6 generations backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 5 generations backK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
- 4 generations backK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
- 3 generations backK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
- 2 generations backK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled
- 1 generation backK131162 Miradry SystemMiramar Labs, Inc. · 2013 · Recalled
- This deviceK150419 miraDry System MD4000Miramar Labs, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −9 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −8 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −7 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −6 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −5 | K052919 | Microsulis Tissue Ablation System | Microsulis Americas, Inc. | 2006 | — |
| −4 | K072870 | Microwave Tissue Coagulation System (MTCS) | Foundry Newco X, Inc. | 2008 | — |
| −3 | K082819 | Dermatologic Treatment System (DTS) G2 | Miramar Labs, Inc. | 2009 | — |
| −2 | K103014 | Miradry System | Miramar Labs, Inc. | 2011 | 2 |
| −1 | K131162 | Miradry System | Miramar Labs, Inc. | 2013 | 1 |
| 0 (this device) | K150419 | miraDry System MD4000 | Miramar Labs, Inc. | 2015 | — |
| +1 | K160141 | miraDry System | Miramar Labs, Inc. | 2016 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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 OUB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K131162 | Miradry SystemSummary page 5…Page 2 of 6 Traditional 510(k) – miraDry System MD4000 (K150419) PREDICATE DEVICES The miraDry System MD4000 (K131162). REFERENCE DEVICE The Microwave Delivery System Model MMC-330 (K991456). DEVICE DESCRIPTION The miraDry System MD4000 is a mi… | 2013 |
| † | K991456 | Microwave Delivery System, Model MMC-300 | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160141 | miraDry System | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 9, 2015 | Class II | Z-0234-2016 | Labeling design | Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K160141 (Miramar Labs, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OUB devicesOUB Instrument For Treatment Of Hyperhidrosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OUB
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · OUB
Too few OUB 510(k)s in any year since 2007 to give a median.
Recalls per year · OUB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUB
52in 2025
MAUDE reports naming product code OUB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 1 | — | 1 | 58 |
| 2016 | 0 | — | 0 | 65 |
| 2017 | 0 | — | 0 | 48 |
| 2018 | 0 | — | 0 | 131 |
| 2019 | 0 | — | 0 | 96 |
| 2020 | 0 | — | 0 | 39 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 41 |
| 2023 | 0 | — | 0 | 49 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 0 | — | 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150419: miraDry System MD4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150419
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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