Cabochon Aesthetics, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Cabochon Aesthetics, Inc.” (first 2014, latest 2014), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 105 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 |
|---|---|---|
| 2014 | 1 | 105 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OUP | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | 2 | 1 |
Review panels
Most recent Cabochon Aesthetics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K134010 | CABOCHON SYSTEM | OUP | 2014-04-14 | 105 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN110004 | De Novo | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | 2013-07-12 |
Recalls
openFDA lists no recalls under a recalling firm named Cabochon Aesthetics, 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 Cabochon Aesthetics, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Cabochon Aesthetics, Inc.” (first 2014, latest 2014), plus 1 De Novo decision, 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 Cabochon Aesthetics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cabochon Aesthetics, Inc. is 105 days.
Which FDA product codes appear under Cabochon Aesthetics, Inc.?
The most frequent FDA product codes under this applicant name are OUP (Powered Surgical Instrument For Improvement In The Appearance Of Cellulite, 2).
Next steps
- See all 1 Cabochon Aesthetics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OUP, Cabochon Aesthetics, 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.