Question 1

What types of medical devices does Geske Beauty Tech GmbH manufacture?

Accepted Answer

Geske Beauty Tech GmbH specializes in handheld devices classified as physical therapy transcutaneous neuromuscular electrical stimulation (TENS) systems. Specifically, their products are marketed as microcurrent pens and lifters, designed to deliver low-level electrical currents for facial rejuvenation. These devices are intended to stimulate muscle contractions and improve skin tone in areas like the face and neck.

Question 2

Where is Geske Beauty Tech GmbH based?

Accepted Answer

Geske Beauty Tech GmbH is based in the United States. The company’s headquarters and operations are located within the country, which is also where its devices are developed and manufactured.

Question 3

Which regulatory registries list Geske Beauty Tech GmbH’s devices?

Accepted Answer

Geske Beauty Tech GmbH’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries are used to track and authorize Class II medical devices in compliance with U.S. regulatory requirements.

Question 4

How are Geske Beauty Tech GmbH’s devices classified under FDA regulations?

Accepted Answer

Geske Beauty Tech GmbH’s devices are classified as Class II medical devices under FDA regulations. This classification applies to products that pose moderate risk and require special controls to ensure safety and effectiveness, such as electrical stimulation devices intended for facial rejuvenation.

Device	Model / Reference	Registries	Class	Status
MicroCurrent Face-Lift Pen 6 in 1	Purple	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	Starlight	FDA UDI	Class II	Active
MicroCurrent Face-Lifter 6 in 1	Starlight	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	Magenta	FDA UDI	Class II	Active
MicroCurrent Face-Lifter 6 in 1	Gray	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	Green	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	Hello Kitty Purple	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	Midnight	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	Hello Kitty Pink	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	Turquoise	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	Gray	FDA UDI	Class II	Active
MicroCurrent Face-Lifter 6 in 1	Magenta	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	White	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	Aquamarine	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	Pink	FDA UDI	Class II	Active
MicroCurrent Face-Lifter 6 in 1	Black	FDA UDI	Class II	Active
MicroCurrent Face-Lifter 6 in 1	Green	FDA UDI	Class II	Active
MicroCurrent Face-Lift Pen 6 in 1	Black	FDA UDI	Class II	Active
SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1	K250361	FDA 510(k)	Class II	Active

Geske Beauty Tech GmbH

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