Theradome, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Theradome, Inc.” (first 2012, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time under this name: 135 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 | 1 | 135 |
| 2013 | 1 | 262 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 29 |
| 2017 | 0 | — |
| 2018 | 2 | 148 |
| 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 Theradome, Inc. took a median 148 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAP | Laser, Comb, Hair | 5 | 5 |
Review panels
Most recent Theradome, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180460 | Theradome LH40 | OAP | 2018-05-18 | 87 |
| K171775 | Theradome LH80 PRO | OAP | 2018-01-09 | 209 |
| K161046 | Laser Helmet LH40-EVO | OAP | 2016-05-12 | 29 |
| K122950 | LASER HELMET | OAP | 2013-06-14 | 262 |
| K113097 | LASER HELMET | OAP | 2012-03-02 | 135 |
Recalls
openFDA lists no recalls under a recalling firm named Theradome, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Theradome, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Theradome, Inc.” (first 2012, latest 2018), across 1 product code 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 Theradome, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Theradome, Inc. is 135 days.
Which FDA product codes appear under Theradome, Inc.?
The most frequent FDA product codes under this applicant name are OAP (Laser, Comb, Hair, 5).
Next steps
- See all 5 Theradome, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OAP, Theradome, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.