Miramar Labs, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Miramar Labs, Inc.” (first 2009, latest 2018), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 148 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 184 |
| 2014 | 0 | — |
| 2015 | 1 | 121 |
| 2016 | 1 | 284 |
| 2017 | 0 | — |
| 2018 | 1 | 30 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Miramar Labs, Inc. took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 151 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEY | System, Ablation, Microwave And Accessories | 3 | 3 |
| OUB | Instrument For Treatment Of Hyperhidrosis | 3 | 3 |
Review panels
Most recent Miramar Labs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180396 | miraDry System | NEY | 2018-03-15 | 30 |
| K160141 | miraDry System | NEY | 2016-10-31 | 284 |
| K150419 | miraDry System MD4000 | OUB | 2015-06-19 | 121 |
| K131162 | MIRADRY SYSTEM | OUB | 2013-10-25 | 184 |
| K103014 | MIRADRY SYSTEM | OUB | 2011-01-28 | 107 |
| K082819 | DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 | NEY | 2009-03-20 | 176 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-10-09.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Miramar Labs, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01732497: A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System (Completed, started 2012-09)
- NCT01091129: Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis (Completed, started 2010-02)
- NCT00931359: Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis (Completed, started 2009-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Miramar Labs, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Miramar Labs, Inc.” (first 2009, latest 2018), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Miramar Labs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Miramar Labs, Inc. is 148 days.
Which FDA product codes appear under Miramar Labs, Inc.?
The most frequent FDA product codes under this applicant name are NEY (System, Ablation, Microwave And Accessories, 3); OUB (Instrument For Treatment Of Hyperhidrosis, 3).
Next steps
- See all 6 Miramar Labs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NEY, Miramar Labs, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.