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Found 12 results
510(k) Data Aggregation
K Number
K243035Device Name
Ulthera® System
Manufacturer
Ulthera, Inc.
Date Cleared
2025-02-24
(150 days)
Product Code
OHV, IYO
Regulation Number
878.4590Why did this record match?
Applicant Name (Manufacturer) :
Ulthera, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.
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, which can also affect the appearance of lax tissue in the submental and neck regions
- Improve lines and wrinkles of the décolleté
- Improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms
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 Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera® System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.
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K Number
K233996Device Name
Ulthera System (UC-1 Control Unit PRIME)
Manufacturer
Ulthera, Inc.
Date Cleared
2024-02-22
(66 days)
Product Code
OHV
Regulation Number
878.4590Why did this record match?
Applicant Name (Manufacturer) :
Ulthera, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.
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. which can also affect the appearance of lax tissue in the submental and neck regions
· Improve lines and wrinkles of the décolleté
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 Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera® System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.
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K Number
K192185Device Name
The Cellfina System
Manufacturer
Ulthera, Inc
Date Cleared
2019-10-09
(58 days)
Product Code
OUP
Regulation Number
878.4790Why did this record match?
Applicant Name (Manufacturer) :
Ulthera, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cellfina System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits through five years of observation.
Device Description
The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 50-use motor module (CM1).
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K Number
K180623Device Name
Ulthera System
Manufacturer
Ulthera, Inc
Date Cleared
2018-05-04
(56 days)
Product Code
OHV, IYO
Regulation Number
878.4590Why did this record match?
Applicant Name (Manufacturer) :
Ulthera, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to:
· lift the eyebrow
• Ift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions
· improve lines and wrinkles of the décolleté
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 inaging 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 Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.
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K Number
K161885Device Name
The Cellfina System
Manufacturer
ULTHERA, INC.
Date Cleared
2016-10-05
(86 days)
Product Code
OUP
Regulation Number
878.4790Why did this record match?
Applicant Name (Manufacturer) :
ULTHERA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 3 years of observation.
Device Description
The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 50-use motor module (CM1).
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K Number
K153677Device Name
The Cellfina System
Manufacturer
ULTHERA, INC.
Date Cleared
2016-02-25
(66 days)
Product Code
OUP
Regulation Number
878.4790Why did this record match?
Applicant Name (Manufacturer) :
ULTHERA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 years of observation.
Device Description
The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 15-use motor module (CM1).
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K Number
K150505Device Name
Cellfina System
Manufacturer
ULTHERA, INC.
Date Cleared
2015-07-29
(154 days)
Product Code
OUP
Regulation Number
878.4790Why did this record match?
Applicant Name (Manufacturer) :
ULTHERA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 vears of observation.
Device Description
The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The release of subcutaneous tissue for improvement in the appearance of cellulite is a minimally invasive surgical technique by physicians using of manual surgical instruments and accessories. The Cellfina device consists of a powered cutting blade and a means for instrument guidance to control the depth, size and shape of the tissue release. The system consists of a sterile single use disposable kit and a non-sterile reusable motor module.
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K Number
K134032Device Name
ULTHERA SYSTEM
Manufacturer
ULTHERA, INC.
Date Cleared
2014-06-20
(171 days)
Product Code
OHV, IYO
Regulation Number
878.4590Why did this record match?
Applicant Name (Manufacturer) :
ULTHERA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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
- improve lines and wrinkles of the décolleté
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 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
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K Number
K132028Device Name
ULTHERA SYSTEM
Manufacturer
ULTHERA, INC.
Date Cleared
2013-12-11
(163 days)
Product Code
OHV, IYO
Regulation Number
878.4590Why did this record match?
Applicant Name (Manufacturer) :
ULTHERA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 .
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 .
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K Number
K121700Device Name
ULTHERA SYSTEM
Manufacturer
ULTHERA, INC.
Date Cleared
2012-10-02
(117 days)
Product Code
OHV
Regulation Number
878.4590Why did this record match?
Applicant Name (Manufacturer) :
ULTHERA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 .
Device Description
The Ulthera System consists of the following components: Ulthera® Control Unit . Handpiece . . Transducers
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