Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016050935

FEI Number

3016050935

Entity Name

TIGER AESTHETICS MEDICAL-57

City/State/Country

Franklin, WI, US

Establishment Address

9900-A S 57th Street, Franklin, WI 53132, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tiger Aesthetics Medical (Owner Number: 10090709)

Owner / Operator Contact Address

5870 Pacific Center Blvd, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P070004

All Registered Proprietary Names

Sientra OPUS Silicone Gel Breast Impant Sizer Sientra Silicone Gel Breast Implants

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRD	Mammary Sizer	Unknown	Class U	N/A	2024-05-02
FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled	General, Plastic Surgery	Class 3	878.3540	2024-05-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tiger Aesthetics Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018544165	TIGER AESTHETICS MEDICAL-54	Franklin, WI, US
3003707320	Tiger Aesthetics Medical-SD	San Diego, CA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-04	N/A	3	McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016050935. Last updated year: 2026. Please use registration number 3016050935 when referencing this establishment in official correspondence.