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510(k) Data Aggregation
K Number
K130250Device Name
QYAG LASER SYSTEM
Manufacturer
PALOMAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
2013-05-03
(91 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PALOMAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark ( i.e. dark blue or black) ink tattoo removal, removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions (- e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal.
Device Description
The QYAG Laser handpiece is an accessory to the Palomar ICON System, which is composed of a system console, cooling system, power supply and handpiece. Laser energy is produced in the handpiece and delivered directly to the tissue.
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K Number
K120622Device Name
PALOMAR VECTUS LASER
Manufacturer
PALOMAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
2012-05-23
(83 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PALOMAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Palomar Vectus Laser is intended for all Fitzpatrick skin types, including tanned skin for use in aesthetic, dermatology, general and plastic surgery applications for the treatment of
- · The treatment of vascular lesions, such as angiomas, telangiectasia and other benign vascular lesions.
- Treatment of leg veins.
- · The treatment of benign pigmented lesions.
- · Hair removal and permanent hair reduction.
- · Treatment of pseudofolliculitis barbae.
The Skintel™ Reader is intended as an objective measurement tool for examining skin. melanin content for determining and setting a test spot starting fluence.
Device Description
The Palomar Vectus Laser consists of a diode-powered handpiece, Skintel Reader, base module, coolant reservoir, and chiller module. The handpiece connects to the base module via the umbilical.
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K Number
K110907Device Name
PALOMAR ICON (TM) AESTHETIC SYSTEM
Manufacturer
PALOMAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
2011-06-22
(83 days)
Product Code
GEX, ONG
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PALOMAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions.
The 2940 Fractional Ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.
The 1540 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The 1440 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The IR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; verrucae, skin tags, seborrheic keratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments; treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (PFB).
The Max Series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
The Skintel™ Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.
Device Description
The Palomar Icon Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces individually connect to the system via the console connection port.
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K Number
K103664Device Name
PRIMUS AESTHETIC PLATFORM
Manufacturer
PALOMAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
2011-03-17
(91 days)
Product Code
ONG, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PALOMAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions.
The 2940 Ablative Laser Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.
The 1540 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, fine lines, textural irregularities, dyschromia and pigmented lesions.
he 1440 and 2940 Fractional combined treatment is intended for dermatological procedures quiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin surfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, schromia and pigmented lesions.
The IR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local culation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; verrucae, skin tags, seborrheic keratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (PFB).
The Max Series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
Device Description
The Palomar Icon Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces individually connect to the system via the console connection port.
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K Number
K101506Device Name
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
Manufacturer
PALOMAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
2010-09-01
(92 days)
Product Code
ONG, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PALOMAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lux1540 and Lux2940 fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The Lux1440 and Lux2940 fractional combined treatment is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
Device Description
The complete platform consists of a cart, console with an internal power supply and electronics, chiller, and a footswitch. Each handpiece individually attaches to the console via a connection port.
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K Number
K100270Device Name
ARTISAN AESTHETIC SYSTEM
Manufacturer
PALOMAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
2010-03-29
(59 days)
Product Code
GEX, ONF, ONG
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PALOMAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The Lux1440 Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.
The Lux2940 Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions. The Lux2940 Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The MaxG Handpiece is intended for treatment of benign pigmented epidermal and cutaneous lesions, including but not limited to lentigines, nevi, melasma, café-au-lait warts, scars, striae, and the treatment of vascular lesions including but not limited to port wine stains, hemangiomas, angiomas, telangiectasias, rosecea, facial and leg veins.
Device Description
The Artisan Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces connect to the system via the console connection port.
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K Number
K090195Device Name
PALOMAR LUX1540 HANDPIECE
Manufacturer
PALOMAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
2009-11-20
(297 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PALOMAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Palomar Lux1540™ Handpiece is intended for use in: Coagulation of soft tissue; Skin resurfacing procedures; Treatment of melasma and striae; Treatment of acne scars and surgical scars.
Device Description
The Lux1540 Handpiece attaches to the StarLux Pulsed Light and Laser Systems. The complete system consists of a cart, system console, chiller, a footswitch, and a handpiece.
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K Number
K070298Device Name
MODIFICATION TO PALOMAR LUXIR HANDPIECE
Manufacturer
PALOMAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
2007-07-03
(153 days)
Product Code
GEX, STA
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PALOMAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LuxIR is intended for photocoagulation of soft tissue in dermatologic applications. It also provides topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Device Description
The LuxIR Handpiece is an accessory to the StarLux™ Pulsed Laser and Light System. The complete StarLux Pulsed Light System consists of a cart, system console, chiller, a footswitch, and a handpiece. The Palomar LuxIR Handpiece emits energy in the infrared wavelength.
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K Number
K063571Device Name
PALOMAR LUX2940 HANDPIECE
Manufacturer
PALOMAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
2007-02-09
(72 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PALOMAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Palomar Lux2940 handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications:
- Skin resurfacing .
- Treatment of wrinkles .
- Epidermal nevi .
- Telangiectasia .
- Spider veins ●
- Actinic chelitis .
- Keloids .
- Verrucae .
- Skin tags .
- Anal tags .
- Keratoses .
- Scar revision (including acne scars) .
- Debulking benign tumors .
- Debulking cysts .
- Superficial skin lesions
Device Description
The Lux2940 handpiece is composed of a system console, cooling system, power supply and handpiece.
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K Number
K060839Device Name
ABC HAIR REMOVAL SYSTEM
Manufacturer
PALOMAR MEDICAL TECHNOLOGIES, INC.
Date Cleared
2006-12-07
(254 days)
Product Code
OHT, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PALOMAR MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.
Device Description
The ABC Hair Removal System is composed of a base unit, umbilical cord, handpiece, chiller system with chiller coolant, cleaning wipes, ABC lubricant, power supply and safety components.
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