# K090571: Alma Lasers ALEX755 Module

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Ltd.
- Decided: Aug 13, 2009 after 163 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: 7 generations back to K963094 (1996). 28 ancestors in all.
58 later devices descend from it; 1 cites it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070805: Ultrawave II EX 1320, Quanta System Spa (2007) Summary page 1.
- K042474: ARION, Wavelight Laser Technologie AG (2004) Summary page 1.
- K034030: Apogee Elite, Cynosure, Inc. (2004) Summary page 1.
- K031488: Cynosure Apogee-TKS II Dermatological Laser, Cynosure, Inc. (2003) Summary page 1.
- K992757: Cynosure Apogee-TKS Dermatological Laser, Cynosure, Inc. (2000) Summary page 1.
- K040055: Polylase LP, Ddc Technologies, Inc. (2004) Summary page 1.
- K010715: AL-40, Ddc Technologies, Inc. (2001) Summary page 1.
- K032991: Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPX, Light Age, Inc. (2004) Summary page 1.
- K973354: Sharplan Epitouch Alexandrite Laser System (5000), Sharplan Lasers, Inc. (1997) Summary page 1.
- K971874: Sharplan Epitouch Alexandrite Laser System (5000), Sharplan Lasers, Inc. (1997) Summary page 1.

## Most influential descendants
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own
- K143519: The MeDioStar NeXT Family (2015), 32 descendants of its own
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (2018), 22 descendants of its own
- K222064: The Alma Soprano Titanium (2022), 14 descendants of its own
- K180719: InMode Diolaze System (2018), 13 descendants of its own

## Indications for use
The Alma Lasers ALEX755 Module to be used with the Harmony XLTM Multi-Application Platform is indicated for permanent hair reduction. Also indicated for the treatment of vascular lesions and benign pigmented lesions.

Source page: https://510kreport.com/device/K090571
Methodology: https://510kreport.com/methodology