Bellus Medical, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Bellus Medical, LLC”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QAI | Powered Microneedle Device | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160029 | De Novo | Powered Microneedle Device | 2018-03-01 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-01-18.
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 Bellus Medical, LLC is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03803059: Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck (Completed, started 2019-01-31)
- NCT02646917: SkinPen Efficacy on Acne Scars on the Face and/or Back (Completed, started 2015-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bellus Medical, LLC?
FDA lists 0 510(k) clearances under the applicant name “Bellus Medical, LLC”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Bellus Medical, LLC?
The most frequent FDA product codes under this applicant name are QAI (Powered Microneedle Device, 1).
Next steps
- See all 0 Bellus Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code QAI, Bellus Medical, 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.