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Alma Diode Tabletop Laser

Alma, Ltd.

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

Alma, Ltd.
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

3
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Cited as predicate

3
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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

3

K160952 references 3 predicate/reference devices

Cited as predicate

3

3 submissions cite K160952 as a predicate