FlexSys

Primary DI
B12510700
Brand
FlexSys
Company
GME German Medical Engineering GmbH
Model
1070
Catalog number
1070
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.
Published
2021-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203054000FlexSysGme German Medical Engineering GmbH2021-03-05GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B12510700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342234451
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B12510600TwinScan 808/755 Laser System106010602019-11-29
B12510420C + B Pelo104210422018-04-16
B12510500LinScan105010502018-11-20
B12510000ExSys 308100010002018-04-16

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