Aesthetic and Reconstructive Technologies, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Aesthetic and Reconstructive Technologies, Inc.” (first 2002, latest 2003), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| MIB | Elastomer, Silicone Block | 4 | 4 |
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| KGZ | Accessories, Catheter | 1 | 1 |
| LZK | Implant, Malar | 1 | 1 |
| MDA | Elastomer, Silicone, For Scar Management | 1 | 1 |
| MIC | Implant, Muscle, Pectoralis | 1 | 1 |
Review panels
Most recent Aesthetic and Reconstructive Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023678 | DIMISIL SCAR GEL | MDA | 2003-01-23 | 83 |
| K022306 | AART SILICONE TUBING | KGZ | 2002-10-10 | 86 |
| K022511 | AART CALF IMPLANT | MIB | 2002-08-26 | 27 |
| K022223 | AART SILICONE SHEETING | MIB | 2002-08-08 | 30 |
| K021839 | AART GLUTEAL IMPLANT | MIB | 2002-07-16 | 42 |
| K021820 | AART SILICONE CARVING BLOCK | MIB | 2002-07-16 | 42 |
| K021337 | AART PECTORALIS IMPLANT | MIC | 2002-07-03 | 68 |
| K021419 | AART MALAR IMPLANT | LZK | 2002-07-02 | 60 |
| K021418 | AART NASAL IMPLANT | FZE | 2002-07-02 | 60 |
| K021417 | AART CHIN IMPLANT | FWP | 2002-07-02 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Aesthetic and Reconstructive Technologies, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Aesthetic Technology, Ltd. (4 510(k)s)
- Aesthetic Lasers, Inc. (1 510(k)s)
- Aesthetic Management Partners (1 510(k)s)
- Aesthetic-Press, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aesthetic and Reconstructive Technologies, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Aesthetic and Reconstructive Technologies, Inc.” (first 2002, latest 2003), across 7 product codes 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 Aesthetic and Reconstructive Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aesthetic and Reconstructive Technologies, Inc. is 60 days.
Which FDA product codes appear under Aesthetic and Reconstructive Technologies, Inc.?
The most frequent FDA product codes under this applicant name are MIB (Elastomer, Silicone Block, 4); FWP (Prosthesis, Chin, Internal, 1); FZE (Prosthesis, Nose, Internal, 1).
Next steps
- See all 10 Aesthetic and Reconstructive Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MIB, Aesthetic and Reconstructive Technologies, 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 (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.