# K212073: Alma Diode Tabletop Laser

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Ltd.
- Decided: Jul 14, 2022 after 377 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: 20 generations back to K943450 (1995). 357 ancestors in all.
No later device cites it as a predicate yet.
0 of 358 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160952: Alma Diode Tabletop Laser, Alma, Ltd. (2016) Summary page 4.

## Indications for use
Intended Use The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures. Indications for Use 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 rm 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 rm 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 rim 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/K212073
Methodology: https://510kreport.com/methodology