Manufacturer
Alma, Ltd.Alma Diode Tabletop Laser
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K160952
- Device name
- Alma Diode Tabletop Laser
- Company
- Alma, Ltd.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-04-05
- Decision date
- 2016-05-05
- Submission type
- Special
- Technology type
- Diode(AI inferred)
- Clinical applications
- Vascular treatmentBody contouring
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
The Alma 1470nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470nm diode tabletop laser is further indicated for laser assisted lipolysis.
Intended Use
The Alma 1470nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470nm diode tabletop laser is further indicated for laser assisted lipolysis.
Device Description
The Alma Diode Tabletop Laser is comprised of the following major components: 1. The main console unit 2. Pull-back 3. Footswitch 4. Accessories.
Summary parsed at:2026-06-01 06:06:07 UTC
Predicate devices
3Cited as predicate
3Alma Diode Tabletop Laser
Medical diode laser systems (CHARISMA, REGAL)
Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
3 submissions cite K160952 as a predicate