# K160952: Alma Diode Tabletop Laser

- Pathway: 510(k) (Special)
- Applicant: Alma, Ltd.
- Decided: May 5, 2016 after 30 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 356 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 362 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140005: Alma Diode Tabletop Laser, Alma Lasers, Ltd. (2014) Summary page 4.
- K133774: Atoven, Bio-Med USA, Inc. (2014) Summary page 4.
- K100558: Quanta Diode Laser System, Quanta System Spa (2010) Summary page 6.

## Most influential descendants
- K241791: Medical Diode Laser Systems (GBOX-6H,  GBOX-10D , GBOX-12D,  GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (2025), 1 descendant of its own
- K234004: Medical diode laser systems (CHARISMA, REGAL) (2025), 1 descendant of its own
- K262426: Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) (2026), 0 descendants of its own
- K251699: The Botticelli (Model: Athena) (2025), 0 descendants of its own
- K212073: Alma Diode Tabletop Laser (2022), 0 descendants of its own

## Indications for 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. 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 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.

Source page: https://510kreport.com/device/K160952
Methodology: https://510kreport.com/methodology