FlexSys 1070

GUDID B12510700

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.

GME German Medical Engineering GmbH

Multi-modality skin surface treatment system

• Primary Device ID: B12510700
• NIH Device Record Key: aa535fc0-202c-43fa-bf75-8976aaafb2fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexSys
• Version Model Number: 1070
• Catalog Number: 1070
• Company DUNS: 342234451
• Company Name: GME German Medical Engineering GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B12510700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203054

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-18
• Device Publish Date: 2021-03-10

Devices Manufactured by GME German Medical Engineering GmbH

• B12510700 - FlexSys: 2021-03-18The 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.
• B12510700 - FlexSys: 2021-03-18 The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these
• B12510600 - TwinScan 808/755 Laser System: 2019-12-09 Scanned diode laser 808 nm and 755 nm for hair reduction
• B12510000 - ExSys 308: 2019-02-07 Excimer light 308 nm system
• B12510500 - LinScan: 2018-12-21 scanned diode laser 808 nm for hair reduction
• B12510420 - C + B Pelo: 2018-07-06 Scanned diode laser 808 nm for hair reduction