Data / Medical devices / United States / Tiger Aesthetics Medical-54
Tiger Aesthetics Medical-54: FDA-registered device maker in Franklin, WI, United States, 3 510(k) clearances and 1 PMA approval
Tiger Aesthetics Medical-54 is registered with the FDA (registration 3018544165) in Franklin, WI, United States. It lists 6 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated May 10, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018544165
- Address
- 9630 S 54th Street, Franklin, WI, United States, 53132
- Owner or operator
- Tiger Aesthetics Medical (10090709)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 2, 2024
- Registered through
- 2026
- Brand names listed
- Cannula Kit, Retractor - Tiger View, Sientra Portfinder, Sientra Silicone Gel Breast Implants, Tiger Guard Implant Delivery Device, Viality
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Specification developer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Complaint file establishment | accessdata.fda.gov |
| Lipoaspirate Washing System For Aesthetic Body Contouring | QKL | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | FTR | 3 | Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment | accessdata.fda.gov |
| Tissue Expander And Accessories | LCJ | U | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 10, 2023 | K221127 | Sientra, inc. Portfinder | LCJ | Substantially Equivalent | Sientra, Inc. | accessdata.fda.gov |
| October 28, 2014 | K140383 | ALLOX2 TISSUE EXPANDERS | LCJ | Substantially Equivalent | Specialty Surgical Products, Inc. | accessdata.fda.gov |
| June 22, 2007 | K070303 | SILICONE TISSUE EXPANDER | LCJ | Substantially Equivalent | Specialty Surgical Products | 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 Tissue Expander And Accessories
- All makers of Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- All makers of Lipoaspirate Washing System For Aesthetic Body Contouring
- All makers of Kit, Surgical Instrument, Disposable
- All makers of Retractor
- All makers of Cannula, Surgical, General & Plastic Surgery
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.