Manufacturer
Alma Lasers, Inc.Alma Diode Tabletop Laser
Country / Region:Israel (IL)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
- K212073
- Device name
- Alma Diode Tabletop Laser
- Company
- Alma Lasers, Inc.
- 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
Predicate devices
1Alma Diode Tabletop Laser
K212073 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K212073 as a predicate
