Manufacturer

Lutronic

South KoreaLegal entities : Cynosure Lutronic Technology Corporation, Lutronic Corporation

Markets : Belgium · Bulgaria · Cyprus · France · Germany · Greece · Latvia · Netherlands · Poland · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 31 · class II · latest in 2026 · see on the FDA website

EU representative : Emergo Europe B.V. (Netherlands)

11 categories, 29 models including 17 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Laser surgery instruments - other	Z12011099	C1 Cap/Roller set, C1 Cap/C5 Tip, C1 Cap/Comb Tip(Optional), C1 Cap/Square Tip(Optional)3 refs Comb Tip MOSAIC 3D LaseMD Ultra C1 Cap / C5 Tip LaseMD Ultra (no longer marketed) Intense Pulsed Light93/42 (no longer marketed) 1 other Thulium laser2 refs93/42 (no longer marketed)	I, IIb MDR, 93/42	EUDAMED record Report an error
Neodymium surgical laser	Z12011017	8mm-Zoom-Collimated handpiece (Tip type: Stick type), 8mm-Zoom-Collimated handpiece (Tip type: [Optional] Semicircle type), [Optional] Zoom handpiece (Tip type: Stick type), [Optional] Zoom handpiece (Tip type: Semicircle type), [Optional] 2mm-SD5853 refs Frequency Doubled Q-switched Nd-YAG Laser3 refs93/42 HOLLYWOOD SPECTRA 2mm-SD585 HOLLYWOOD SPECTRA (no longer marketed)	I, IIb MDR, 93/42	EUDAMED record Report an error
Carbon dioxide surgical laser	Z12011005	Laser System main body (Including Handpiece) eCO2 DENTA Laser System main body (Including Handpiece) eCO2 3D Surgical CO2 Laser(RF Type)93/42	IIb MDR, 93/42	EUDAMED record Report an error
Multi-platform laser	Z12011019	12 mm, 14 mm, 16 mm cartridge (Optional) DermaV CLARITY II (ICD Type) CLARITY II, CLARITY II LPA3 refs 12 mm, 14 mm, 16 mm cartridge DermaV (no longer marketed) CLARITY II (AIR Type) CLARITY II, CLARITY II LPA3 refs (no longer marketed) Long-pulsed Alexandrite+Nd:YAG Laser2 refs93/42 (no longer marketed) 1 other Long-pulsed Nd:YAG Laser93/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
Electrosurgical units (ESU) for general use	Z12010902	Electrosurgical Unit2 refs93/42 G49D LUTRONIC GENIUS	IIb MDR, 93/42	EUDAMED record Report an error
Laser surgery instruments - hardware accessories	Z12011080	F50 handpiece,F100 handpiece,Zoom handpiece,F100 connector,F100 connector_D,Zoom connector,Zoom connector_D,F50 Tip head 90,F50 Tip head 120,F100 Tip head 90,F100 Tip head 120,F100 Tip head 180,Defocus Tip head,F50 Normal Tip,F50 Normal Tip_D3 refs Static Tip 120, Static Tip 300, Static Tip 500, Static Tip Set, F100 handpiece, F100 connector, F100 connector_D, F100 normal tip, F50 handpiece, F50 Normal tip, F50 Normal Tip_D, Zoom handpiece, Zoom connector, Zoom connector_D3 refs	I MDR	EUDAMED record Report an error
General medicine therapeutic treatment instruments - other	Z12040299	HEAD-830nm/590nm HEALITE II Phototherapy Unit93/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Electrosurgery instruments - consumables	Z12010985	LUT-ICD 550A	I MDR	EUDAMED record Report an error
Dye/alexandrite surgical laser No model still on the market	Z12011012	Long-pulsed Alexandrite Laser2 refs93/42 (no longer marketed)	IIb 93/42	EUDAMED record Report an error
Erbium surgical laser No model still on the market	Z12011014	Pulsed Er-YAG Laser93/42 (no longer marketed)	IIb 93/42	EUDAMED record Report an error
Magnetotherapy equipment No model still on the market	Z120606	Electromagnetic Stimulator93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error

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