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AMI INC.

South Korea·KR-MF-000017522

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Dermaxel	AMI-CL-0411	EUDAMED	Class IIb	Active
Rex-Q	AMI-CL-0331A	EUDAMED	Class IIb	Active
Rex-Q Plus	AMI-CL-0332A	EUDAMED	Class IIb	Active
Viola	AMI-CL-0811	EUDAMED	Class IIa	Active
Antige	AMI-CL-0911	EUDAMED	Class IIb	Active
Bioxel	BIOXEL	EUDAMEDFDA UDI	Class IIb	Active
Rex-An Dual	AMI-CL-0621	EUDAMED	Class IIb	Active
Haclre	AMI-CL-0211	EUDAMED	Class IIb	Active
Rex-An Alex	AMI-CL-0622	EUDAMED	Class IIb	Active
Dx300	AMI-CL-0541	EUDAMED	Class IIb	Active
Picosecond Nd:YAG Laser System; PICO LEGEND	K233007	FDA 510(k)	Class II	Active
Fractional CO2 Surgical Laser System	K173359	FDA 510(k)	Class II	Active
Solray	AMI-CL-0711	EUDAMED	Class IIa	Active
Bx300	AMI-CL-0531	EUDAMED	Class IIb	Active
Allux-Q Plus	AMI-CL-0332	EUDAMED	Class IIb	Active
Ann-36	AMI-CL-0911	EUDAMED	Class IIb	Active
Q-Master Plus	AMI-CL-0322	EUDAMED	Class IIb	Active
ALLUX Nd:YAG	AMI-CL-0613	EUDAMED	Class IIb	Active
Neoxel	AMI-CL-0511	EUDAMED	Class IIb	Active
Hi-Rex	AMI-CL-0841	EUDAMED	Class IIa	Active
Mt-Smart	AMI-CL-0941	EUDAMED	Class IIb	Active
Rex-Co	AMI-CL-0421	EUDAMED	Class IIb	Active
REX-AN Nd:YAG	AMI-CL-0623	EUDAMED	Class IIb	Active
Rex-Light	AMI-CL-0711	EUDAMED	Class IIa	Active
Allux-Q	AMI-CL-0331	EUDAMED	Class IIb	Active
Q-Master	AMI-CL-0321	EUDAMEDFDA UDI	Class IIb	Active
Ani-36	AMI-CL-0911	EUDAMED	Class IIb	Active
Pico Legend	AMI-CL-1011	EUDAMEDFDA UDI	Class IIb	Active
Allux Alex	AMI-CL-0612	EUDAMED	Class IIb	Active
Di-Rex	AMI-CL-0221	EUDAMED	Class IIb	Active
Pico Master	AMI-CL-1021	EUDAMED	Class IIb	Active
Allux Dual	AMI-CL-0611	EUDAMED	Class IIb	Active
Ant-36	AMI-CL-0911	EUDAMED	Class IIb	Active

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