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510(k) Data Aggregation
K Number
K160952Device Name
Alma Diode Tabletop Laser
Manufacturer
ALMA LTD
Date Cleared
2016-05-05
(30 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ALMA LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.
Indications for Use
laser assisted lipolysis.
The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order. Diode Laser Modules:
The indications for use for the 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.
The indications for use for the 980 nm Alma Diode Tabletop Laser include: -The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis.
The indications for use for the 1470 nm Alma Diode Tabletop Laser include: -The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for
Device Description
The Alma Diode Tabletop Laser is comprised of the following major components:
- The main console unit 1.
- 2. Pull-back
- 3. Footswitch
- Accessories 4.
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