Silhouette Lift, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Silhouette Lift, Inc.” (first 2015, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 66 days. Since 2017 the median was 48 days, against 130 days for all cleared 510(k)s in the same product codes. 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 | 1 | 268 |
| 2016 | 0 | — |
| 2017 | 2 | 100 |
| 2018 | 0 | — |
| 2019 | 1 | 31 |
| 2020 | 1 | 66 |
| 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 Silhouette Lift, Inc. took a median 48 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 3 | 3 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | 2 |
Review panels
Most recent Silhouette Lift, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200140 | Silhouette Instalift | GAM | 2020-03-27 | 66 |
| K191299 | Silhouette Featherlift / Silhouette Lift | GAW | 2019-06-14 | 31 |
| K163676 | Silhouette InstaLift | GAM | 2017-06-16 | 171 |
| K171005 | Silhouette Featherlift | GAW | 2017-05-03 | 29 |
| K142061 | SILHOUETTE INSTALIFT | GAM | 2015-04-24 | 268 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-07-02.
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.
- Silhouette Optical , Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Silhouette Lift, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Silhouette Lift, Inc.” (first 2015, latest 2020), across 2 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 Silhouette Lift, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Silhouette Lift, Inc. is 66 days. Since 2017: 48 days, versus 130 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Silhouette Lift, Inc.?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 3); GAW (Suture, Nonabsorbable, Synthetic, Polypropylene, 2).
Next steps
- See all 5 Silhouette Lift, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAM, Silhouette Lift, 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.