# K080318: Alma Laser Nir Module

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Ltd.
- Decided: Mar 7, 2008 after 30 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K910422 (1992). 48 ancestors in all.
184 later devices descend from it; 3 cite it directly.
0 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050370: Palomar Luxir Handpiece, Palomar Medical Technologies, Inc. (2005) Summary page 1.
- K042165: Cutera Tabletop Aesthetic Product, Cutera, Inc. (2004) Summary page 1.
- K033768: Altus Medical Optional Infrared Handpiece, Altus Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms (2010), 124 descendants of its own
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application (2011), 118 descendants of its own
- K083595: Ezlase (2009), 58 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own
- K123483: Diode Laser (2013), 53 descendants of its own

## Indications for use
The Alma Lasers NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Source page: https://510kreport.com/device/K080318
Methodology: https://510kreport.com/methodology