510(k) Report

FDA applicant

Miramar Labs, Inc.

Santa Clara, CA6 decisions2009–20182 recalls

FDA records 6 decisions for Miramar Labs, Inc. (Santa Clara, CA) from 2009 to 2018: 6 510(k) clearances. Most are in product codes NEY (System, Ablation, Microwave And Accessories) and OUB (Instrument For Treatment Of Hyperhidrosis). Its devices cite 6 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Miramar Labs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2009: 12011: 12013: 12015: 12016: 12018: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2015

2011: 12015: 1
2009high 1 (2011) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Miramar Labs, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Miramar Labs, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NEYSystem, Ablation, Microwave And Accessories3decisions
  • OUBInstrument For Treatment Of Hyperhidrosis3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K103014Miradry SystemMiramar Labs, Inc. · 20112cite it
  • K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 20092cite it
  • K160141miraDry SystemMiramar Labs, Inc. · 20161cites it
  • K131162Miradry SystemMiramar Labs, Inc. · 20131cites it
  • K150419miraDry System MD4000Miramar Labs, Inc. · 20151cites it

What has FDA decided for it lately?

  • K180396miraDry SystemMiramar Labs, Inc. · 2018
  • K160141miraDry SystemMiramar Labs, Inc. · 2016
  • K150419miraDry System MD4000Miramar Labs, Inc. · 20151 recall
  • K131162Miradry SystemMiramar Labs, Inc. · 20131 recall
  • K103014Miradry SystemMiramar Labs, Inc. · 20112 recalls
  • K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009

All 6 as Miramar Labs, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K103014miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and…Oct 9, 2015Class II
  • K103014MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the…Apr 24, 2011