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Deka Bluebeam

El.En S.P.A.

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

El.En S.P.A.
Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K243683
Device name
Deka Bluebeam
Company
El.En S.P.A.
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-11-29
Decision date
2025-06-12
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cuttingOther
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The DEKA BlueBeam is a medical device intended for incision, excision, vaporization, ablation, hemostasis and coagulation of body soft tissue.

Intended Use

The DEKA BlueBeam is a medical device intended for incision, excision, vaporization, ablation, hemostasis and coagulation of body soft tissue.

Device Description

The DEKA BLUEBEAM is a diode laser engineered to enhance performance in surgical applications. The DEKA BLUEBEAM electrical specifications are: 100-230V~, 50/60Hz, 300VA.

Summary parsed at:2026-06-01 05:21:45 UTC

Predicate devices

1

K243683 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K243683 as a predicate