Manufacturer
Ceramoptec GmbHLeonardo Mini Blue
Country / Region:Germany (DE)Submission type:Abbreviated
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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—
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Not ingested
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Not ingested
Wolf445nm
K210951 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K210951 as a predicate