Capillus, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Capillus, LLC” (first 2015, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 78 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 |
|---|---|---|
| 2015 | 3 | 84 |
| 2016 | 3 | 32 |
| 2017 | 1 | 78 |
| 2018 | 0 | — |
| 2019 | 1 | 45 |
| 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 Capillus, LLC took a median 62 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 | 8 | 8 |
Review panels
Most recent Capillus, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192012 | Capillus 112, Capillus 244 | OAP | 2019-09-12 | 45 |
| K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 | OAP | 2017-01-31 | 78 |
| K162994 | Capillus302, Capillus312, Capillus352 | OAP | 2016-11-18 | 22 |
| K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | OAP | 2016-04-25 | 82 |
| K153618 | Capillus202 | OAP | 2016-01-19 | 32 |
| K151516 | Capillus82 | OAP | 2015-08-21 | 77 |
| K150578 | Capillus 272 Office Pro | OAP | 2015-06-09 | 92 |
| K143199 | Capillus 272 Pro | OAP | 2015-01-29 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Capillus, LLC.
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 Capillus, LLC is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01967277: A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy (Completed, started 2014-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Capillus, LLC?
FDA lists 8 510(k) clearances under the applicant name “Capillus, LLC” (first 2015, latest 2019), 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 Capillus, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Capillus, LLC is 78 days.
Which FDA product codes appear under Capillus, LLC?
The most frequent FDA product codes under this applicant name are OAP (Laser, Comb, Hair, 8).
Next steps
- See all 8 Capillus, LLC clearances with predicates and recalls
- Run predicate analysis for product code OAP, Capillus, LLC'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.