Data / Medical devices / United States / Tiger Aesthetics Medical-57
Tiger Aesthetics Medical-57: FDA-registered device maker in Franklin, WI, United States, 1 510(k) clearance and 1 PMA approval
Tiger Aesthetics Medical-57 is registered with the FDA (registration 3016050935) in Franklin, WI, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated November 16, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016050935
- Address
- 9900-A S 57th Street, Franklin, WI, United States, 53132
- Owner or operator
- Tiger Aesthetics Medical (10090709)
- Roles
- Manufacturer
- First device listed
- May 2, 2024
- Registered through
- 2026
- Brand names listed
- Sientra OPUS Silicone Gel Breast Impant Sizer, Sientra Silicone Gel Breast Implants
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mammary Sizer | MRD | U | Manufacturer | accessdata.fda.gov |
| Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | FTR | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 16, 2020 | K200706 | Sientra OPUS Silicone Gel Breast Implant Sizer | MRD | Substantially Equivalent | Sientra, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 9, 2012 | P070004 | SIENTRA SILICONE GEL BREAST IMPLANTS | FTR | 42 | April 22, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- All makers of Mammary Sizer
Updated April 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.