Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi

NIDEK INCORPORATED

FDA registration

NIDEK INCORPORATED·2 products·🇺🇸 United States

NIDEK CO., LTD.

FDA registration

NIDEK CO., LTD.·2 products·🇯🇵 Japan

NIDEK CO., LTD.

FDA registration

NIDEK CO., LTD.·2 products·🇯🇵 Japan

VisuMax Laser Keratome

FDA registration

CARL ZEISS MEDITEC AG (JENA)·2 products·🇩🇪 Germany

Peregrine3901 (PL) - Powered laser surgical instrument

FDA registration

Isomedix Operations Inc.·2 products·🇺🇸 United States

Ax0x000 (bending laser probes, 20g/23g/25g)

FDA registration

OPHTHALMED LLC·2 products·🇺🇸 United States

LION

FDA registration

NORLASE APS·2 products·🇩🇰 Denmark

TruScan Pro

FDA registration

LIGHTMED CORP.·2 products·🇹🇼 Taiwan

E2 Compact Microprobe and Endoscopy System

FDA registration

Beaver-Visitec International, Inc·2 products·🇺🇸 United States

NIDEK INCORPORATED

FDA registration

NIDEK INCORPORATED·2 products·🇺🇸 United States

NIDEK INCORPORATED

FDA registration

NIDEK INCORPORATED·2 products·🇺🇸 United States

Tecfen Laser Probes

FDA registration

TECFEN MEDICAL·2 products·🇺🇸 United States

ZEISS VISULAS YAG II Laser

FDA registration

CARL ZEISS MEDITEC AG (JENA)·2 products·🇩🇪 Germany

KEELER LTD.

FDA registration

KEELER LTD.·2 products·🇬🇧 United Kingdom

Integre LP5532

FDA registration

Ellex Medical Pty Ltd·2 products·🇦🇺 Australia

LENSAR Laser System -fs 3D (LLS-fs 3D)

FDA registration

LENSAR, Inc·2 products·🇺🇸 United States

NIDEK CO., LTD.

FDA registration

NIDEK CO., LTD.·2 products·🇯🇵 Japan

Schneider ASR B.V.

FDA registration

Schneider ASR B.V.·2 products·🇳🇱 Netherlands

OcuLight SL/SLx

FDA registration

Iridex Corporation·2 products·🇺🇸 United States