(117 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
The device is indicated for use in a non-invasive dermatological aesthetic treatment to lift the eyebrow and lift lax submental and neck tissue, which is a therapeutic purpose.
No
The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to lift tissue, not to diagnose a condition or disease.
No
The device description explicitly lists hardware components: Ulthera® Control Unit, Handpiece, and Transducers.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "non-invasive dermatological aesthetic treatment to lift the eyebrow, lift lax submental (beneath the chin) and neck tissue." This describes a therapeutic or aesthetic procedure performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The components listed (Control Unit, Handpiece, Transducers) are consistent with a device that delivers energy or treatment to the body, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Ulthera System's function is clearly in vivo (within the body) for aesthetic treatment.
N/A
Intended Use / Indications for Use
The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to:
- lift the eyebrow.
- lift lax submental (beneath the chin) and neck tissue.
Product codes
OHV
Device Description
The Ulthera System consists of the following components: Ulthera® Control Unit, Handpiece, Transducers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyebrow, submental (beneath the chin) and neck tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Ulthera® System was evaluated in an open-label clinical trial investigating the clinical response following treatment with the Ulthera® System to achieve lifting of lax submental (beneath the chin) and neck tissue. Improvement was evaluated through quantitative assessment, qualitative assessment and patient satisfaction questionnaires. There were 51/70 patients that had an improvement of ≥20 mm² in lift, of these patients 84.3% were identified as showing improvement by masked evaluators. The adverse events resulting from treatment with the Ulthera® System during this study were mild, short-lived in duration, and resolved without incident. There were no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment with the Ulthera® System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
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510(k) Summary
This 510(k) Summary for the Ulthera "System is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Ulthera, Inc. |
|---|---|
| Address: | 2150 South Country Club Drive, Suite 21 |
| Mesa, AZ 85210 | |
| Contact Person: | Suzon Lommel, VP of Regulatory & Quality Affairs |
| Telephone: | 480-649-4069 |
| Fax: | 480-619-4071 |
| Submission Date: | June 7, 2012 |
| Device Trade Name: | Ulthera® System |
| Common Name: | Focused Ultrasound Stimulator Use System for Aesthetic Use |
| Classification: | Regulatory Class II |
| Classification Name: | Focused Ultrasound Stimulator Use System for Aesthetic Use |
| Product Code: | OHV |
| Legally Marketed | Name: Ulthera® System |
| Predicates: | 510(k): #K072505 |
| Applicable Guidance: | The Class II Special Controls Guidance Document: Focused Ultrasound |
| Stimulator System for Aesthetic Use was developed in response to Ulthera's | |
| DeNovo submission and 510(k) clearance K0272505 for the Ulthera System. |
Image /page/0/Picture/6 description: The image shows the word "ulthera" in a stylized font. The letters are outlined in black, and there are three small circles above the "e" in "ulthera". The word appears to be a logo or brand name.
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The Ulthera System consists of the following components: Device Description: Ulthera® Control Unit . Handpiece . . Transducers The Ulthera System is indicated for use as a non-invasive dermatological Indications for Use: aesthetic treatment to: lift the eyebrow (current cleared indication) . . lift lax submental (beneath the chin) and neck tissue {requested expanded indication) To support the expanded indication, the Ulthera® System was evaluated in Performance Data: an open-label clinical trial investigating the clinical response following treatment with the Ulthera® System to achieve lifting of lax submental (beneath the chin) and neck tissue. Improvement was evaluated through quantitative assessment, qualitative assessment and patient satisfaction questionnaires. There were 51/70 patients that had an improvement of ≥20 mm² in lift, of these patients 84.3% were identified as showing improvement by masked evaluators. The adverse events resulting from treatment with the Ulthera® System during this study were mild, short-lived in duration, and resolved without incident. There were no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment with the Ulthera® System. Conclusion: Based on the design, materials, principle of operation, and intended use, the Ulthera® System is substantially equivalent to the legally marketed predicate device.
Image /page/1/Picture/1 description: The image shows the word "Ulthera" in a stylized font. The letters are outlined, giving them a distinct appearance. Above the "era" portion of the word, there are three small circles arranged horizontally.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ulthera, Incorporated % Ms. Suzon Lommel Vice President of Regulatory & Quality Affairs 2150 South Country Club Drive, Suite 21 Mesa, Arizona 85210
OCT 2 2012
Re: K121700
Trade/Device Name: Ulthera® System Regulation Number: 21 CFR 878.4590 Regulation Name: Focused ultrasound stimulator system for aesthetic use Regulatory Class: Class II Product Code: OHV Dated: August 1, 2012 Received: August 3, 2012
Dear Ms. Lommel:
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, listing 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 - Ms. Suzon Lommel
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRHOffices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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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Indications for Use Statement
K121700 510(k) Number:
Ulthera® System Device Name:
Indications for Use:
The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to:
- lift the eyebrow .
- lift lax submental (beneath the chin) and neck tissue .
Prescription Use ____x (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121700
Indications for Use Statement