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Leonardo Mini Blue

Ceramoptec GmbH

Country / region:Germany (DE)Submission type:Abbreviated

Product code GEX· 21 CFR 878.4810

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Company

Ceramoptec GmbH
Germany (DE)

Product code

GEX
21 CFR 878.4810

Predicate devices

3
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K210951
Device name
Leonardo Mini Blue
Company
Ceramoptec GmbH
Country / region
Germany(DE)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-03-30
Decision date
2021-09-01
Submission type
Abbreviated
Technology type
Diode(AI inferred)
Clinical applications
Surgical cuttingOtherOtherOther
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Leonardo Mini Blue 445nm Laser is intended for incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

Intended Use

The Leonardo Mini Blue 445nm Laser is intended for incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

Device Description

The laser family LEONARDO® Mini Blue is a laser system with functions and ergonomics specially developed for medical applications. A control panel is used to set treatment parameters, such as laser power. User-friendly menu navigation ensures a reliable operation while allowing physicians to concentrate on the essential aspects of treatment.

Summary parsed at:2026-06-01 05:42:54 UTC

Predicate devices

3

K210951 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K210951 as a predicate