Aesthetech Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Aesthetech Corp.” (first 1981, latest 1987), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 44 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 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
| LCJ | Tissue Expander And Accessories | 1 | 1 |
| LZK | Implant, Malar | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Aesthetech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873940 | CREAT BRAND O-RISE GENERAL ASPIRATOR | BTA | 1987-11-25 | 58 |
| K873434 | CREAT BRAND MALAR IMPLANT | LZK | 1987-09-11 | 16 |
| K853189 | CREAT BRAND I/A PACK CREAT BRAND PHACO PACK | HQC | 1985-09-24 | 56 |
| K843678 | CREAT BRAND SKIN EXPANDER | LCJ | 1984-11-06 | 49 |
| K841283 | DISPOSABLE SUCTION TUBING SET | — | 1984-04-24 | 27 |
| K812210 | CREAT BRAND WAGNER CHIN IMPLANT | FWP | 1981-09-11 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Aesthetech Corp..
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 Aesthetech Corp.?
FDA lists 6 510(k) clearances under the applicant name “Aesthetech Corp.” (first 1981, latest 1987), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aesthetech Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aesthetech Corp. is 44 days.
Which FDA product codes appear under Aesthetech Corp.?
The most frequent FDA product codes under this applicant name are BTA (Pump, Portable, Aspiration (Manual Or Powered), 1); FWP (Prosthesis, Chin, Internal, 1); HQC (Unit, Phacofragmentation, 1).
Next steps
- See all 6 Aesthetech Corp. clearances with predicates and recalls
- Run predicate analysis for product code BTA, Aesthetech Corp.'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.