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Lutronic Corporation

South Korea·KR-MF-000009035

Last updated September 17, 2026

What Lutronic Corporation makes

Lutronic Corporation makes dermatological solid-state laser systems, including frequency-doubled and diode laser systems, as well as radio-frequency skin surface treatment and skin/body contouring systems. The company also produces dermatological laser beam guiding handpieces, foot-switches, and general/multiple surgical frequency-doubled solid-state laser systems.

The manufacturer's devices are classified as Class II, Class IIa, and Class IIb and are listed in the EUDAMED, FDA 510(k), and FDA UDI registries. Lutronic Corporation is based in South Korea (KR).

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Lutronic Corporation make?

Where is Lutronic Corporation based?

Lutronic Corporation is based in South Korea (KR).

Which registries list Lutronic Corporation's devices?

Lutronic Corporation's devices are listed in the EUDAMED, FDA 510(k), and FDA UDI registries.

How are Lutronic Corporation's devices classified?

Lutronic Corporation's devices are classified as Class II, Class IIa, and Class IIb.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: South Korea
Address: 219, SOWON-RO, Deogyang-gu, Goyang-si, Gyeonggi-do, South Korea
Website: lutronic.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82-31-908-3440
PRRC Contact: DAEHO CHOI
EUDAMED SRN: KR-MF-000009035
FDA FEI Number: 3013789508
DUNS Number: 688282516

Catalogue (191)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
Xerf	K251327	FDA 510(k)	Class II	Active
Spectra Vrmii 1-Switched Nd:yag Laser System	K073436	FDA 510(k)	Class II	Active
PICOPLUS Laser System	K173700	FDA 510(k)	Class II	Active
Spectra Vrmiii Q-Switched Nd: Yag Laser System And Dye Handpieces	K080248	FDA 510(k)	Class II	Active
Infini Radiofrequency System	K121481	FDA 510(k)	Class II	Active
Spectra Laser System	K113588	FDA 510(k)	Class II	Active
Powerlipo Laser System	K082096	FDA 510(k)	Class II	Active
DermaV Laser System	K203788	FDA 510(k)	Class II	Active
Spectra Laser System	K103455	FDA 510(k)	Class II	Active
Clarity Lpc Laser System	K130199	FDA 510(k)	Class II	Active
Advantage	K141555	FDA 510(k)	Class II	Active
LUTRONIC GENIUS Radiofrequency System	K180945	FDA 510(k)	Class II	Active
Spectra Sp Ii, Spectra Denta Ii	K091320	FDA 510(k)	Class II	Active
ACTION II Laser System	K163196	FDA 510(k)	Class II	Active
CLARITY II Laser System	K183566	FDA 510(k)	Class II	Active
Advantage Laser System	K113502	FDA 510(k)	Class II	Active
Mosaic Eco2 Laser System	K080496	FDA 510(k)	Class II	Active
P14d Box (10ea)	LUTRONIC GENIUS	EUDAMED	Class IIb	Active
12 mm, 14 mm, 16 mm cartridge	DermaV	EUDAMED	Class IIb	Active
GeniusX Handpiece	LUTRONIC GENIUS	EUDAMED	Class IIb	Active
Surgical CO2 Laser(RF Type)	eCO2 Plus	EUDAMED	Class IIb	Active
M49d Box (10ea)	LUTRONIC GENIUS	EUDAMED	Class IIb	Active
8mm-Zoom-Collimated handpiece (Tip type: Stick type)	HOLLYWOOD SPECTRA	EUDAMEDFDA UDI	Class IIb	Active
3mm, 5mm cartridge	CLARITY II, CLARITY II LPA	EUDAMEDFDA UDI	Class IIb	Active
Electromagnetic Stimulator	accucurv	EUDAMED	Class IIa	Active
Multi-Depth Focus handpiece	HOLLYWOOD SPECTRA	EUDAMED	Class IIb	Active
Frequency Doubled Q-switched Nd-YAG Laser	HOLLYWOOD SPECTRA	EUDAMED	Class IIb	Active
Pill Tip BOX	MOSAIC 3D	EUDAMED	Class IIb	Active
Pulsed Er-YAG Laser	ACTION II	EUDAMED	Class IIb	Active
HEAD-830nm/590nm & 415nm	HEALITE II	EUDAMED	Class IIa	Active
S20 Tip BOX	MOSAIC 3D	EUDAMED	Class IIb	Active
M81d Box (10ea)	LUTRONIC GENIUS	EUDAMED	Class IIb	Active
Zoom handpiece (Tip type: Stick type)	HOLLYWOOD SPECTRA	EUDAMEDFDA UDI	Class IIb	Active
GeniusSkin Handpiece	LUTRONIC GENIUS	EUDAMEDFDA UDI	Class IIb	Active
2mm-SD585	HOLLYWOOD SPECTRA	EUDAMEDFDA UDI	Class IIb	Active
C1 Cap / Comb Tip	LaseMD Ultra	EUDAMED	Class IIb	Active
GeniusM Handpiece	LUTRONIC GENIUS	EUDAMEDFDA UDI	Class IIb	Active
Roller Tip Tyvek Pouch	MOSAIC 3D	EUDAMED	Class IIb	Active
Long-pulsed Alexandrite+Nd:YAG Laser	CLARITY II	EUDAMED	Class IIb	Active
Comb Tip BOX	MOSAIC 3D	EUDAMED	Class IIb	Active
O Type IntelliTrak tip	DermaV	EUDAMEDFDA UDI	Class IIb	Active
Pill Tip Tyvek Pouch	MOSAIC 3D	EUDAMED	Class IIb	Active
Sapphire Tip Package	MOSAIC 3D	EUDAMED	Class IIb	Active
Fractional (FRX) cartridge	DermaV	EUDAMED	Class IIb	Active
HEAD-830nm/590nm & 633nm	HEALITE II	EUDAMED	Class IIa	Active
2mm-SD650	HOLLYWOOD SPECTRA	EUDAMEDFDA UDI	Class IIb	Active
Roller Tip Package	MOSAIC 3D	EUDAMED	Class IIb	Active
5mm-SD585	HOLLYWOOD SPECTRA	EUDAMEDFDA UDI	Class IIb	Active
Intense Pulsed Light	SOLARI	EUDAMED	Class IIb	Active
System Main Body	HEALITE II	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Lutronic Corporation Goyang-si Gyeonggi · KR FEI 3013789508