Ceramoptec GmbH

Country / region:United States (US)

510(k) submissions

Latest clearance

2025-07-14

Product codes

GEX

Cited as predicate

Product areas

FDA product code distribution

2 total

K number	Device name	Product code	Class	Decision date
K250504	Leonardo Duster	GEX	Class 2	2025-07-14
K210951	Leonardo Mini Blue	GEX	Class 2	2021-09-01

K113688
—
—
Not ingested
K113709
—
—
Not ingested
K242191
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
Olympus Surgical Technologies America
K113709
—
—
Not ingested
K113858
—
—
Not ingested
K192272
Wolf445nm
A.R.C Laser GmbH

Ceramoptec GmbH references 6 predicate/reference devices

No later 510(k)s cite this device yet

Other submissions will appear here when they list Ceramoptec GmbH as a predicate