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510(k) Data Aggregation
K Number
K201904Device Name
Monet Curing Laser
Manufacturer
CAO Group, Inc.
Date Cleared
2020-11-24
(138 days)
Product Code
QNF, EBZ, GEX
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
CAO Group, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Monet Curing Laser is a source of illumination for curing photo-active materials and adhesives.
Device Description
The Monet Curing Laser is a device for delivering light energy to dental restorative materials and adhesives, which utilize the light energy to affect a photopolymerization reaction. This energy is generated by a solid-state laser diode, which provides a consistent and reliable generation of laser energy at 450 ± 5nm for a maximum of 2.0 watts (2400 mW/cm²) of energy output. The laser energy is delivered to the dental material by means of an optical focusing lens that collimates the laser energy to a nearly parallel beam size that remains highly consistent regardless of distance to the target material. The device also includes a low-intensity aiming beam feature that allows the operator to see the delivery site of the energy without risk of premature polymerization of the material. The device features a metal construction with glass output window that contains all device electronics. The device features a simple on/off switch and set 3-second activation time. The device incorporates a detachable rechargeable battery which is recharged on an accompanying charging stand. The charging stand incorporates a basic radiometer to allow the user to confirm the output intensity of the emitted light.
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K Number
K201475Device Name
Ultimate Contour, Ultimate Contour Mini
Manufacturer
CAO Group, Inc.
Date Cleared
2020-10-28
(147 days)
Product Code
PBX, OHV
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CAO Group, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1) Application of non-thermal radio frequency for 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.
2) Application of ultrasound for non-invasive reduction in abdominal circumference on adults with a Body Mass Index (BMI) of 25 or greater.
Device Description
The Ultimate Contour is a medical device that combines the technologies of radio-frequency energy and ultrasound in one convenient unit. The Ultimate Contour utilizes a single power source and control circuitry that directs the emission of energy based on which operating screen is selected and which applicator handpiece is attached to the unit's delivery cable. Based on the attached handpiece, the Ultimate Contour delivers to the handpiece of the appropriate energy intensity based on the settings selected.
Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.
Delivered ultrasound is accomplished with a piezo transducer located in the ultrasound handpiece that is bonded to the handpiece contact surface. The handpiece is applied directly to the patient skin at the abdominal area and the emitted ultrasound energy focuses within the subdermal fatty tissue, causing reduction in waist circumference.
The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.
The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.
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K Number
K181602Device Name
Pioneer Elite Diode Laser
Manufacturer
CAO Group, Inc.
Date Cleared
2019-09-10
(448 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CAO Group, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pioneer Elite Diode Laser is indicated for dentistry and oral soft tissue procedures of:
1) The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, troughing, and removal of inflamed edematous tissue.
2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
Device Description
The Pioneer Elite Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
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K Number
K181614Device Name
Sterling Supreme Diode Laser
Manufacturer
CAO Group, Inc.
Date Cleared
2019-09-10
(448 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CAO Group, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of:
1) The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue;
2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
Device Description
The Sterling Supreme Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.
The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
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K Number
K181601Device Name
Precise SHP Diode Laser
Manufacturer
CAO Group, Inc.
Date Cleared
2019-09-09
(447 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CAO Group, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Precise SHP Diode Laser is indicated for dentistry and oral soft tissue procedures of:
1) The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, troughing, and removal of inflamed edematous tissue.
2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
Device Description
The Precise SHP Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.
The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
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K Number
K171052Device Name
Ultimate Contour, Ultimate Contour Mini
Manufacturer
CAO Group, Inc.
Date Cleared
2017-10-20
(193 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CAO Group, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Application of non-thermal radio frequency for 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
The Ultimate Contour is a body sculpting device that combines the technologies of radio-frequency in one convenient unit. The Ultimate Contour utilizes a single power source and control circuitry that directs the emission of energy based on which operating screen is selected and which applicator handpiece is attached to the unit's delivery cable. Based on the attached handpiece, the Ultimate Contour delivers to the handpiece the appropriate energy intensity based on the settings selected. Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos. The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.
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K Number
K171986Device Name
Sterling Supreme Diode Laser
Manufacturer
CAO Group, Inc.
Date Cleared
2017-09-22
(81 days)
Product Code
GEX, ILY
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CAO Group, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of:
1) The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue;
2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
Device Description
The Sterling Supreme Diode Laser is a device for delivering laser energy to human soft tissue for a variety of dental and oral procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to the surgical site by means of an optical fiber fully ensheathed within a coated steel coil terminated in a handpiece assembly, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The target tissues absorb the laser energy converting it to heat. Depending on the intensity or power output of the laser, the heat so generated can cause hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 650nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The device allows for selection of factoryestablished presets for common dental and oral care procedures, and allows for the operator to save desired settings for quick-reference.
Laser energy is transmitted through the fixed length of optical fiber to the distal end of the handpiece assembly. The handpiece assembly consists of a reusable, removable, sterilizable handpiece sleeve, and for surgical procedures is terminated with a single-use disposable tip. The operator uses the handpiece assembly to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a wireless foot-actuated switch.
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K Number
K160413Device Name
Sterling 5W Diode Laser
Manufacturer
CAO Group, Inc.
Date Cleared
2016-09-21
(218 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CAO Group, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterling Diode Laser is indicated for: Dental soft tissue indications:
Dental, oral and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tisue, excision and biopsy, gingivectory and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy, and photocoagulation.
Laser periodontal procedures, including:
Laser soft tissue curettage; laser removal of diseased, infected and necrosed soft tissue within the periodontal pocket; removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.
Device Description
The Sterling Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 10nm for a maximum of 5 watts of energy is delivered to the surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The target tissues absorb the laser energy converting it to heat. depending on the intensity or power output of the laser, the heat so generated can cell hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.
The optical fiber is stored within the device and dispensed to the desired length according to the clinician's need. A fiber is passed through a reusable, sterilizeable handpiece assembly and terminated with a single-use disposable tip. The operator uses the handpiece to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a foot-actuated switch.
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K Number
K150585Device Name
Ascent 3D
Manufacturer
CAO GROUP, INC.
Date Cleared
2015-12-31
(297 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
CAO GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For light activated polymerization of dental materials such as composites, luting cements, adhesives, and sealants using visible and near-UV light.
Device Description
The Ascent 3D is a polymerization light source device for delivering light energy to polymerizable dental materials applied to human teeth in conjunction with a variety of procedures and treatments. This energy is generated by solid-state light-emitting diodes (LEDs), which provide a consistent and reliable generation of light energy at 390-520nm with an average optical output of 1600 milliwatts. The LEDs are positioned at the terminal end of the device, allowing for direct illumination of the treatment site without the use of light pipes or other optically conductive appendages. The device features three LEDs that are spatially positioned to illuminate three surfaces or planes of the tooth simultaneously. The device controls allow the operator to select which combination of LEDs are active and the emission time. Emission is initiated by pressing a button, and can be interrupted by pressing the same button or by allowing the selected emission time to expire. The device is constructed of a biocompatible plastic such as ABS, and coated aluminum. The device is powered from an internal rechargeable battery that is charged from an external power supply when not in use.
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K Number
K142223Device Name
Pilot Pro Diode Laser
Manufacturer
CAO GROUP, INC.
Date Cleared
2014-09-12
(30 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CAO GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pilot Pro Diode Laser is indicated for the procedures of removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissue in the fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, dermatology, podiatry, plastic surgery, urology, and gynecology.
Device Description
The Pilot Pro Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 5 watts of energy output. The laser energy is delivered to the surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous emission or pulse emission options. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is removable from the optical fiber system for cleaning and sterilization in between uses. The activation of the working beam diodes is completed by use of a foot-actuated switch.
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