HANSON MEDICAL FACIAL IMPLANTS

K090803 · Hanson Medical, Inc. · FZE · Jun 30, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K090803
• Device Name: HANSON MEDICAL FACIAL IMPLANTS
• Applicant: Hanson Medical, Inc.
• Product Code: FZE · General, Plastic Surgery
• Decision Date: Jun 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Silicone Nasal Implant - For the augmentation or reconstruction of the nasal contour Silicone Malar Implant – For the augmentation or reconstruction of the malar contour Silicone Chin Implant -- For the augmentation or reconstruction of the chin contour

Device Story

Hanson Medical Facial Implants consist of pre-formed silicone devices designed for surgical augmentation or reconstruction of facial features. Implants are intended for nasal, malar, and chin contouring. Devices are implanted by surgeons in a clinical or hospital setting. Implants provide structural support or volume enhancement to facial tissues, aiming to improve aesthetic or reconstructive outcomes for patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Facial implants constructed of medical-grade silicone. Form factor includes pre-formed shapes for nasal, malar, and chin anatomy. Non-active, implantable device.

Indications for Use

Indicated for patients requiring augmentation or reconstruction of nasal, malar, or chin contours.

Regulatory Classification

Identification

A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

Predicate Devices

• Silicone Nasal Implant (K973573)
• Silicone Malar Implant (K973574)
• Silicone Chin Implant (K973575)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized graphic of an eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Hanson Medical, Inc. % Mr. Gerald Hanson P.O. Box 1160 Kingston, Washington 98346

Re: K090803

Trade/Device Name: Hanson Medical Facial Implants Regulation Number: 21 CFR 878.3550 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: FWP, ESR, LZK Dated: June 24, 2010 Received: June 28, 2010

JUN 3 0 2010

Dear Ms. Hanson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Gerald Hanson

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K050803

## TAB D

## INTENDED USE FORM

## 510(k) Number K 973573 Silicone Nasal Implant K 973574 Silicone Malar Implant K 973575 Silicone Chin Implant

Device Name: Hanson Medical Facial Implants

Indications for use:

Silicone Nasal Implant - For the augmentation or reconstruction of the nasal contour

Silicone Malar Implant – For the augmentation or reconstruction of the malar contour

Silicone Chin Implant -- For the augmentation or reconstruction of the chin contour

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off Division of General and Restorative Devices 510(k) numbers K973573, K973574, K973575

Prescription Use

Optional Format 1-2-96

**Division Sign-Off**

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

**510(k) Number**