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510(k) Data Aggregation
K Number
K221623Device Name
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
Manufacturer
Date Cleared
2023-03-10
(277 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GME German Medical Engineering GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies.
Modules UVB EPL 308 and UVB EPL 308 lite:
The GME FlexSys System with module UVB EPL 308 or UVB EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Module Infrared 1550:
The GME FlexSys System with Infrared 1550 module is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
Device Description
The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.
The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition, the power cord, foot switch, and the door plug are connected there. The touch-screen serves as the main control panel.
The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered.
The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.
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K Number
K203054Device Name
FlexSys
Manufacturer
Date Cleared
2021-03-05
(149 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GME German Medical Engineering GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device FlexSys is a multi-modality skin surface treatment . Depending on the chosen modules the intended use and the mode of operation varies.
Module MultiLite:
The intended use of the device FlexSys with MultiLite module is:
· Blue 420 nm light: The GME FlexSys with Blue 420 MultiLite is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
· Yellow 585 nm light: The GME FlexSys with module Yellow 585 is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
· Red 635 nm Light: The GME FlexSys with Red 635 MultiLite is indicated in general to treat dermatological conditions and specifically indicated to treat superficial, benign vascular, and pigmented lesions.
Module Green 532:
The GME FlexSys with module Green 532 (wavelength: 532nm) is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.
Module Yellow 577:
The GME FlexSys with module Yellow 577 (wavelength: 577mm) is intended for treatment of benign vascular and benign pigmented lesions.
Device Description
The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.
The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition the power cord, foot switch, and the door plug are connected to the base unit. The touch-screen serves as the main control panel.
The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered.
The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.
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K Number
K192269Device Name
TwinScan 808/755 Laser System
Manufacturer
Date Cleared
2019-11-19
(90 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GME German Medical Engineering GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GME TwinScan 808/755 Laser System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.
The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-VI).
Device Description
The TwinScan 808/755 Laser System is a diode laser designed to be used in Dermatological practice for stable, long term hair reduction.
The TwinScan 808/755 Laser System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button) that controls an applicator unit. The applicator unit contains the diode laser and scanner. The device may be configured with 808 nm or 755 nm Applicators, in two treatment area sizes, at the factory. The TwinScan 808/755 Laser System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit. A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the TwinScan 808/755 Laser System.
Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The heat denatures the protein of the chromophore (in this case, hair follicle). Specifically, the hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.
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K Number
K180518Device Name
GME LinScan Lite 808 Laser System
Manufacturer
Date Cleared
2018-07-23
(146 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GME German Medical Engineering GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GME LinScan Lite 808 Laser System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9,or 12 months following a treatment regime.
Device Description
The LinScan Lite 808 Laser System is a diode laser designed to be used in Dermatological practice for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.
The LinScan Lite 808 System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button) that controls an applicator unit. The applicator unit contains the diode laser and scanner.
The LinScan Lite 808 System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit.
A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the LinScan Lite 808 System.
Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The heat denatures the protein of the chromophore. Specifically, the hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.
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