FlexSys

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 1070

by GME German Medical Engineering GmbH

Identity

Trade Name: FlexSys EUDAMEDFDA UDI
Generic Name: Multi-modality skin surface treatment system FDA UDI
Device Name: FlexSys EUDAMED
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. FDA UDI
Model / Reference: 1070 EUDAMEDFDA UDI
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. FDA UDI

Identifiers

Catalog Number: 1070 FDA UDI
Primary DI / UDI-DI: +B12510700P EUDAMED
B12510700 FDA UDI
Basic UDI-DI: B-+B12510700P EUDAMED
510(k) Number: K203054 FDA UDI
FDA Product Code: GEX FDA UDI
EMDN Code: Z12011019,Z12040202 EUDAMED
GMDN Term: Multi-modality skin surface treatment system FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

FlexSys by GME German Medical Engineering GmbH — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K203054	Class IIb	Active
EUDAMED	European Union	CE/MDD	B-+B12510700P	Class IIb	Active

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Manufacturer

Manufacturer: GME German Medical Engineering GmbH
EUDAMED SRN: DE-MF-000009384

Sources (3)

EUDAMED 2a0193c5-c084-4708-9e90-9ea964a97b98 61 fields · synced Sep 17, 2026
FDA UDI aa535fc0-202c-43fa-bf75-8976aaafb2fa 35 fields · synced May 30, 2026
FDA 510(k) K203054 1 fields · synced May 18, 2026