Manufacturer
El.En Electronic Engineering SpaDEKA LipoAI
El.En Electronic Engineering Spa
Country / Region:Italy (IT)Submission type:Traditional
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
- K212270
- Device name
- DEKA LipoAI
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-07-20
- Decision date
- 2021-10-21
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Surgical cuttingOtherBody contouringSkin tightening
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The LipoAI is indicated for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The LipoAI is further indicated for laser assisted lipolysis.
Intended Use
The LipoAI is indicated for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The LipoAI is further indicated for laser assisted lipolysis.
Device Description
The LipoAI is a medical laser equipped with a short pulse 1444 nm Nd:YAG laser source. The device delivers the laser energy through a 600 um optical fiber. The fiber is protected by a small stainless-steel cannula (max. 1.4mm) and is inserted in the tissue through a small aperture in the skin. The DEKA LipoAI device consists of: • An AC/DC power supply unit • CPU controller • LASER source • Cooling system • User interface with LCD touch screen • Beam delivery system. Laser activation is controlled by footswitch. Electrical specifications are: 200-240V ~ single phase, 50/60 Hz, Absorbed electric power 3200 VA (max).
Summary parsed at:2026-06-01 05:43:32 UTC
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Cited as predicate
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