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Found 16 results
510(k) Data Aggregation
K Number
K080915Device Name
FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES
Manufacturer
RELIANT TECHNOLOGIES, INC.
Date Cleared
2008-07-01
(90 days)
Product Code
GEX, DEV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
RELIANT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fraxel re:pair (Fraxel III SR) Laser System, including its resurfacing handpiece delivery system, is intended for use in:
-Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.
-Treatment of wrinkles, rhytides, furrows, fine lines;
-Pigmented lesions;
-Textural irregularities;
-Vascular dyschromia.
The Fraxel re:pair (Fraxel III SR) Laser System, including its incisional and debulking delivery systems, are intended for ablation (removal), for the reduction, treatment and/or removal of:
- Actinic and seborrheic keratoses;
-Chelitis;
-Cutaneous horns;
-Hemangiomas;
-Keloids;
-Nevi, including spider, epidermal and protruding;
-Rhinophyma;
-Syringomas;
-Warts;
-Laser incision and/or excision for the performance of upper and lower eyelid blepharoplasty and vermilionectomy of the lip.
Device Description
The Fraxel re:pair Laser System consists of a CO2 laser source and three delivery handpieces for resurfacing, incision and debulking procedures. Each handpiece attaches to an articulating arm. Additional device accessories include interchangeable resurfacing treatment tips, incisional handpiece spatulas, and debulking handpiece spatulas.
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K Number
K071051Device Name
FRAXEL III SR LASER SYSTEM AND ACCESSORIES
Manufacturer
RELIANT TECHNOLOGIES, INC.
Date Cleared
2007-11-02
(203 days)
Product Code
GEX, DEV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
RELIANT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fraxel III SR Laser System and accessories is intended for use in:
Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.
Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
Device Description
The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.
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K Number
K071621Device Name
RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES
Manufacturer
RELIANT TECHNOLOGIES, INC.
Date Cleared
2007-10-09
(117 days)
Product Code
GEX, DEV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
RELIANT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Skin cooling in conjunction with drinatological laser treatments to reduce pain and thermal damage to skin tissue.
Device Description
The C300 Chiller System is a thermoelectric cooler (TECs) which utilizes the Peltier effect. The chiller employs solid-state heat pumps that cool thermoelectrically and contain no moving parts. The C300 Chiller System is contained within a single housing. The chiller console is electrically connected to a standard 110 VAC wall outlet. The unit delivers low temperature air at an adjustable rate through a treatment tube. The user interacts with the C300 Chiller System by turning the power switch to the on position and selecting the desired temperature via the display on the digital controller
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K Number
K070284Device Name
FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)
Manufacturer
RELIANT TECHNOLOGIES, INC.
Date Cleared
2007-05-17
(108 days)
Product Code
GEX, DEV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
RELIANT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fraxel® SR 1500 Laser System and accessories is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of acne scars and surgical scars; Photocoagulation for treatment of dyschromia and pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis and melasma; Skin resurfacing procedures.
Device Description
The Fraxel® SR1500 Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
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K Number
K063038Device Name
FRAXEL III SR LASER SYSTEM AND ACCESSORIES
Manufacturer
RELIANT TECHNOLOGIES, INC.
Date Cleared
2007-04-27
(207 days)
Product Code
GEX, DEV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
RELIANT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fraxel III SR Laser System and accessories is intended for use in:
Dermatological procedures requiring ablation (removal), coagulation and resurfacing of soft tissue.
Device Description
The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.
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K Number
K063808Device Name
FRAXEL IV SR LASER SYSTEM
Manufacturer
RELIANT TECHNOLOGIES, INC.
Date Cleared
2007-04-27
(126 days)
Product Code
GEX, DEV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
RELIANT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fraxel IV SR Laser System and accessories is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of acne scars and surgical scars;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;
Skin resurfacing procedures.
Device Description
The Fraxel IV SR Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the skin.
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K Number
K062303Device Name
FRAXEL II SR LASER SYSTEM
Manufacturer
RELIANT TECHNOLOGIES, INC.
Date Cleared
2007-01-31
(176 days)
Product Code
GEX, DEV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
RELIANT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fraxel II SR Laser System and accessories is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of acne scars and surgical scars;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;
Skin resurfacing procedures.
Device Description
The Fraxel II SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
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K Number
K060310Device Name
FRAXEL II SR LASER SYSTEM AND ACCESSORIES
Manufacturer
RELIANT TECHNOLOGIES, INC.
Date Cleared
2006-03-29
(50 days)
Product Code
GEX, DEV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
RELIANT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia;
Skin resurfacing procedures.
Device Description
The Fraxel II SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
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K Number
K053047Device Name
FRAXEL SR LASER SYSTEM
Manufacturer
RELIANT TECHNOLOGIES, INC.
Date Cleared
2006-03-20
(143 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
RELIANT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reliant Laser System II and accessories (Fraxel SR Laser System) is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of surgical scars and acne scars;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;
Skin resurfacing procedures.
Device Description
The Fraxel SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments.
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K Number
K050841Device Name
FRAXEL SR LASER SYSTEM
Manufacturer
RELIANT TECHNOLOGIES, INC.
Date Cleared
2005-07-05
(95 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
RELIANT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reliant Laser System II is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;
Skin resurfacing procedures.
Device Description
The Fraxel SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments.
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