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510(k) Data Aggregation
K Number
K231092Device Name
T-SHAPE 2
Manufacturer
B&M S.R.L. Marketing Nel Benessere
Date Cleared
2023-09-22
(157 days)
Product Code
NUV, PBX
Regulation Number
878.4810Why did this record match?
Product Code :
NUV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T-SHAPE 2 and its hand pieces are indicated for the relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.
Device Description
T-SHAPE 2 treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.
The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an targeted manner.
T-SHAPE 2 is also equipped with:
- Two light sources type inside some handpieces (see below) with the following wavelengths: 650 and l 980 nm.
- -Electrodes for bipolar RF energy (500 kHz/ 1 MHz / 1,5 MHz).
Through the display, the light sources and RF energy can be fully deactivated or activated.
The light sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
For the RF energy the user can select frequency between 2 MHz, 1 MHz, 500 kHz and intensity between the 10 levels available.
T-SHAPE 2 comprises a main console unit and several handpieces.
A microprocessor-based system controller is used to monitor and direct all the system function and the graphic user interface.
The main console can be connected to the following handpieces (two different hand piece can be connected at the same time):
- -Large multipole handpiece with 6 diode laser and 6 RF plates;
- -Medium multipole handpiece with 4 diode laser and 4 RF plates;
- -Small multipole handpiece 4 RF plates and 1 red LED;
- -Thermal imaging camera;
- -Roll handpiece with 4 diode laser and 2 motorized roller with RF;
- -Mesosphere handpiece with 45 motorized rotating spheres.
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K Number
K211272Device Name
ICOONE Laser Med (also referred to as ICOONE Medical laser)
Manufacturer
I-Tech Industries SRL
Date Cleared
2021-06-22
(56 days)
Product Code
NUV, ISA
Regulation Number
878.4810Why did this record match?
Product Code :
NUV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ICOONE Laser med (also referred to as ICOONE Medical laser) is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
Device Description
Icoone Medical Laser (also referred to as Icoone Lase med) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an absolutely targeted manner. Icoone Medical Laser (model ref 650EC24) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650mm (50mW) - Laser @ 915mm (1W) Through the display, the light sources can be fully deactivated, or only LED activated. The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW). Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time. The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
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K Number
K182453Device Name
ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)
Manufacturer
I-TECH INDUSTRIES SRL
Date Cleared
2019-01-11
(126 days)
Product Code
NUV
Regulation Number
878.4810Why did this record match?
Product Code :
NUV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ICOONE h is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
Device Description
The Icoone-h device is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body.
lcoone-h Laser is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths:
LED @ 650nm (50Mw) Laser @ 915nm (1W)
The light sources can be activated through the display, either combined or independently (only one of the two or both).
The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time.
The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
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K Number
K161892Device Name
Slimming Treatment Device
Manufacturer
BEIJING HONKON TECHNOLOGIES CO., LTD
Date Cleared
2017-03-02
(234 days)
Product Code
NUV, ISA
Regulation Number
878.4810Why did this record match?
Product Code :
NUV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.
Device Description
The HONKON-Slimming I+ and HONKON-Slimming III+ are the non-invasive body shaping product to combine four different technologies including IR (infrared), Bi-Polar RF (radio-frequency) and mechanical tissue manipulation using pulsed vacuum and massage rollers. The combination of the IR and vacuum coupled RF technologies causes deep heating of the connective tissue including the fibrous septae which in turn promotes an increase in local cellular reduction. The additional mechanical tissue manipulation of the device causes an immediate increase in circulation and lymphatic drainage, both essential components for healthy skin structure.
The HONKON-Slimming I+ and HONKON-Slimming III+ can output infrared light with wavelength 700-2000nm, the infrared light can penetrate whole skin tissue. The infrared light has the effect to expand blood vessels, temporary improvement of local blood circulation; At the same time, this spectrum has a good efficacy for temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences..
The HONKON-Slimming I+ and HONKON-Slimming III+ can output 1MHz frequency, produce RF energy from X, Y and Z directions in the subcutaneous tissue. Temperature of skin tissues becomes higher, Enzyme activity was enhanced so that fat cells can be fully released within the triglyceride; Triglycerides in the fat under the action of enzymes, cracking into fatty acids and glycerol.
Massage rollers has obvious mechanical compression to skin tissues. Meanwhile, deep negative pressure gives skin and muscles full relaxation and rest. Maximum 8kg negative pressure can absorb all skin tissues into the gap between the bipolar RF tips, ensure RF energy can reach fat layers.
Based on this,the HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences..
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K Number
K131362Device Name
INMODE WMBODY DEVICE
Manufacturer
INMODE MD LTD.
Date Cleared
2013-10-08
(148 days)
Product Code
NUV, ISA
Regulation Number
878.4810Why did this record match?
Product Code :
NUV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InMode WMbody device is intended for the treatment of the following medical conditions, using the WMbody applicator for delivering non-thermal RF combined with massage:
- · Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of blood circulation; and
- Temporary reduction in the appearance of cellulite. ●
Device Description
The InMode WMbody device is designed to deliver mechanical vacuum skin massaging and nonthermal RF energy to the skin and subdermal fat. RF energy does not cause thermal damage to the treated skin and adipose tissue.
The device provides individual adjustment of non-thermal RF power and vacuum pulse duration to achieve maximum efficiency and safety for each patient. The ergonomic hand piece allows efficient treatment of large tissue surfaces.
The InMode WMbody device consists of an AC/DC power supply unit, RF generator, controller and user interface including a LCD screen and functional buttons. The hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a vacuum pump, vacuum chamber with two electrodes and a pressure sensor.
Following are the InMode WMbody device specifications: RF Output Power: 10-50 Watt RF Output Frequency: 1[MHz] ± 2% Dimension: 36cm W x 36cm D x 100cm H (14.2" W x 14.2" D x 40'' H) Weight: 30 Kg (66 lbs) Main Line Frequency (nominal): 50-60 Hz Inout Voltage (nominal): 100-240 VAC
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K Number
K122579Device Name
VELASHAPE
Manufacturer
SYNERON MEDICAL LTD.
Date Cleared
2012-09-13
(21 days)
Product Code
NUV, MUV
Regulation Number
878.4810Why did this record match?
Product Code :
NUV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.
Device Description
The VelaShape treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.
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K Number
K101147Device Name
MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
Manufacturer
ALMA LASERS, INC.
Date Cleared
2011-01-21
(273 days)
Product Code
NUV, GEI, ISA
Regulation Number
878.4810Why did this record match?
Product Code :
NUV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of Accent™ RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with unipolar and bipolar handpieces.
The massager component of the Alma Lasers Accent UniForm Handpiece is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide:
Temporary reduction in the appearance of cellulite. .
Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide:
Temporary reduction in the appearance of cellulite. .
Device Description
The Alma Lasers Accent Elite system similar to Accent™ RF Systems [Accent, Accent XL } is comprised of the following main components:
. Console
a Bipolar RF module
A Unipolar RF module (UniLarge)
A UniForm (RF and Massage) module
. Control panel
Footswitch. .
Modules are used to deliver radiofrequency energy to the treatment site. Each RF module consists of the following components:
. Handle - used for holding the module
. Trigger - activates the radiofrequency energy emission when pressed in Ready mode
Applicator tip establishes contact with the patient's skin .
. Thermoelectric cooler - integrated within the module, provides internal module cooling
. RF emission indicator - blue LED illuminates prior to- and during RF emission
Umbilical cable contains coolant tubes. RF-power cable and the communication . cable that controls the operation of the module
. Module connector - connects the module to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip which stores information about the module and the parameter settings.
The UniForm module additionally employs a massaging mechanism that works in conjunction with the RF energy application.
The Accent Elite is a computerized system with embedded software that controls its operation. The software also runs the graphical user interface, which enables user-friendly control of the system operation.
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K Number
K101366Device Name
I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)
Manufacturer
CHROMOGENEX TECHNOLOGIES LTD
Date Cleared
2010-09-17
(123 days)
Product Code
NUV, ILY
Regulation Number
878.4810Why did this record match?
Product Code :
NUV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The i-lipo™ Ultra Vacuum Massage System is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. The i-lipo™ Ultra Treatment Pads and Probes are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.
Device Description
The i-lipo™ Ultra System consists of a main unit, and applied parts (massage head with rollers and various laser diode cluster probes and pads). The Main Unit contains the mains input, fuses, power supply, pump, relay, control circuits, LCD display, membrane function buttons, emergency stop, and key switch. The massage head, and cluster probes and pads, which are placed against the patients skin, contain the rollers, and Laser diodes, Laser light provides topical heating which increases tissue temperature, and the rollers in combination with the vacuum mechanically manipulate the tissue.
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K Number
K100230Device Name
SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V
Manufacturer
ELEME MEDICAL, INC.
Date Cleared
2010-04-02
(66 days)
Product Code
NUV
Regulation Number
878.4810Why did this record match?
Product Code :
NUV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Elemé Medical SMOOTHSHAPES XV system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
Device Description
The SMOOTHSHAPES XV System featuring Photomology® technology is designed to temporarily reduce the appearance of cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to temporarily reduce the appearance of cellulite.
Photomology is based on the transcutaneous application of a dynamic combination of dual-band laser/light. The Photomology Module combines 650 nm light from LEDs and 915 nm light from laser diodes with mechanical massage (rollers) and vacuum (suction).
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K Number
K092195Device Name
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
Manufacturer
CUTERA, INC.
Date Cleared
2009-10-01
(72 days)
Product Code
NUV, GEI, ISA
Regulation Number
878.4810Why did this record match?
Product Code :
NUV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cutera CMMCD optional infrared/RF device is indicated for the relief of minor muscle aches and pains, relief of muscle spasms, temporary improvement in local circulation. The Cutera CMMCD massage device is indicated for the temporary improvement in the appearance of cellulite.
The Cutera CMMCD infrared(optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
The Cutera CMMCD massage device is intended to provide a temporary reduction in the appearance of cellulite.
Device Description
The Cutera CMMCD treatment consists a massage device and an infrared light(optional)/RF device. Topical heating for the purpose of elevating tissue temperature is derived from conducted RF energy/optional infrared light. Mechanical manipulation is derived from a vacuum assisted massage with rollers. The pneumatic/mechanical manipulation of the skin is sufficient to provide mild transient erythema and produces a temporary improvement in the appearance of cellulitic skin where applied.
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