Alma Diode Tabletop Laser

Alma Lasers, Inc.

Country / region:Israel (IL)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Israel (IL)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

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0

Device details

FDA 510(k) registration fields

K number
K212073
Device name
Alma Diode Tabletop Laser
Country / region
Israel(IL)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-07-02
Decision date
2022-07-14
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cuttingVascular treatment
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures. The indications for use for the 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm diode tabletop laser is indicated for endoluminal or 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 laser assisted lipolysis.

Intended Use

The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures. The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order. The indications for use for the 810 nm Alma Diode Tabletop Laser include: The Alma 810 nm diode tabletop laser is indicated for endoluminal or 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 laser assisted lipolysis.

Device Description

The Diode Tabletop System is a small, tabletop laser console that can be sold with one of three wavelengths – 1470nm, 980nm or 810nm. It is comprised of 4 major components. The main console unit contains the laser module, controller, cooling and user interface. The Footswitch is used to activate the laser. The diode laser modules are contained in the main console and emit laser energy in the required wavelength. All of the accessories connect via a fiber to the SMA connection port on the laser console. A single use, radial emitting fiber will be provided sterile by an OEM manufacturer. The fiber is sterilized using ETO. It is for prescription use only.

Summary parsed at:2026-06-01 05:38:20 UTC

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