The Ulthera System in conjunction with the Ulthera DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to:

. ensure proper coupling of the transducer to the skin
confirm appropriate depth of treatment such as to avoid bone .

Device Description

The Ulthera System consists of the following components:

. Ulthera Control Unit
Handpiece .
Transducers .

AI/ML Overview

The provided text describes an FDA 510(k) summary for the Ulthera® System. However, it explicitly states:

"No new performance testing was performed to support the new Performance Data: indications. There have been no changes to previously cleared device (K121700, Ulthera® System) that would result in a new 510(k). Imaging capabilities of the Ulthera® System have been included in the device's profile since the original clearance. Clinical literature and ultrasound images were provided."
"There have been no changes to previously cleared Ulthera® System Conclusion: (K121700) that would result in a new 510(k)."

This means that this specific submission (K132028) did not conduct a new study to prove acceptance criteria because it's a re-submission for minor changes or clarifications, not new performance claims. The device relies on its previous clearances (K121700 and K072505 for the Ulthera System, and K983945 for the predicate device DermaScan C) for performance data.

Therefore, a detailed table of acceptance criteria and reported device performance from this specific document against a new study is not available. The document asserts substantial equivalence to predicate devices based on design, materials, principle of operation, and intended use, and provides no new performance data or study details for the current submission.

Summary based on the provided document:

Table of Acceptance Criteria and Reported Device Performance: This document does not present new acceptance criteria or reported device performance data from a new study. It relies on the performance proven for the predicate devices and prior clearances of the Ulthera System.
Sample Size and Data Provenance for Test Set: Not applicable for this submission as no new performance testing was conducted.
Number and Qualifications of Experts for Ground Truth: Not applicable for this submission as no new performance testing was conducted.
Adjudication Method for Test Set: Not applicable for this submission as no new performance testing was conducted.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable for this submission. The document doesn't mention any MRMC study.
Standalone Performance Study: Not applicable for this submission as no new performance testing was conducted.
Type of Ground Truth Used: Not applicable for this submission as no new performance testing was conducted.
Sample Size for Training Set: Not applicable for this submission as no new machine learning algorithm development requiring a training set is described.
How Ground Truth for Training Set Was Established: Not applicable for this submission.

Conclusion from the document:
The Ulthera System's imaging subsystem is considered equivalent to the predicate device, DermaScan C (K983945), in terms of "patient contact material biocompatibility, electromagnetic compatibility, and medical electrical safety standards" as well as "general specifications, device settings and intended use." This equivalence forms the basis of its clearance for the stated indications without the need for new performance studies in this specific 510(k) submission.

Summary

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5. 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:	1840 South Stapley DriveSuite 200Mesa, AZ 85204
Contact Person:	Suzon Lommel, VP of Regulatory & Quality Affairs
Telephone:	480-619-4069
Fax:	480-619-4071
Submission Date:	June 28, 2013
Device Trade Name:	Ulthera® System
Common Name:	Focused Ultrasound For Tissue Heat Or Mechanical Cellular DisruptionSystem, Imaging, Pulsed Echo, Ultrasonic
Classification:	Regulatory Class II
Classification Name:	Focused Ultrasound Stimulator Use System for Aesthetic Use
Regulation:	878.4590
Product Code:	OHVIYO
Legally Marketed	Name: Ulthera® System
Predicates:	510(k):Ulthera, Inc., Ulthera System - K121700Cortex Technology, DermaScan C - K983945
Applicable Guidance:	The Class II Special Controls Guidance Document: Focused UltrasoundStimulator System for Aesthetic Use was developed in response to

Image /page/0/Picture/5 description: The image shows the word "Ulthera" in a stylized font. The "U" and "l" are tall and thin, while the rest of the letters are shorter and wider. There are three small circles above the "h" in "Ulthera". The word "Ulthera" is in black, and the background is white.

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Ulthera's DeNovo submission and 510(k) clearance K072505 for the Ulthera System.

Guidance for Industry and FDA Staff: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

Device Description:

The Ulthera System consists of the following components:

. Ulthera Control Unit
Handpiece .
Transducers .

Indications for Use:

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:

lift the eyebrow (current cleared indication) .
lift lax submental (beneath the chin) and neck tissue (cleared . indication)

ensure proper coupling of the transducer to the skin (requested . indication)
confirm appropriate depth of treatment such as to avoid bone . (requested indication)

No new performance testing was performed to support the new Performance Data: indications. There have been no changes to previously cleared device (K121700, Ulthera® System) that would result in a new 510(k). Imaging capabilities of the Ulthera® System have been included in the device's profile since the original clearance. Clinical literature and ultrasound images were provided.

There have been no changes to previously cleared Ulthera® System Conclusion: (K121700) that would result in a new 510(k).

The Ulthera System's imaging subsystem and the DermaScan C are equivalent in terms of patient contact material biocompatibility, electromagnetic compatibility, and medical electrical safety standards. The Ulthera System's imaging subsystem is equivalent in terms of general

Page | 05-2

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specifications, device settings and intended use to the predicate device, DermaScan C (K983945).

Based on the design, materials, principle of operation, and intended use, the Ulthera® System is substantially equivalent to the legally marketed predicate devices.

Image /page/2/Picture/2 description: The image shows the word "ulthera" in a stylized font. The "u" and "l" are represented by three vertical lines, and the rest of the word is in a sans-serif font. Above the "thera" portion of the word are three small circles. The letters are bolded and have a textured appearance.

Page 3 of 3

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002

Ulthera Incorporated Ms. Suzon Lommel Vice President of Regulatory & Quality Affairs 1840 South Stapley Drive, Suite 200 Mesa, Arizona 85204

December 11, 2013

Re: K132028

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, IYO Dated: October 25, 2013 Received: October 28, 2013

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Suzon Lommel

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

510(k) Number: Unknown

Device Name: Ulthera® System

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 .

. ensure proper coupling of the transducer to the skin
confirm appropriate depth of treatment such as to avoid bone .

Prescription Use	ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
(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)
Long H. Chen - A	for BSA
(Division Sign-off)
Division of Surgical Devices
510(k) Number:	K132028

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Regulation Number and Section

§ 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.