# K042474: ARION

- Pathway: 510(k) (Traditional)
- Applicant: Wavelight Laser Technologie AG
- Decided: Sep 29, 2004 after 16 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: 6 generations back to K963094 (1996). 20 ancestors in all.
114 later devices descend from it; 2 cite it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983977: Light Age Epicare Alexandrite Laser, Light Age, Inc. (1999) Summary page 1.
- K971874: Sharplan Epitouch Alexandrite Laser System (5000), Sharplan Lasers, Inc. (1997) Summary page 1.
- K973354: Sharplan Epitouch Alexandrite Laser System (5000), Sharplan Lasers, Inc. (1997) Summary page 1.
- K024260: Candela Gentlelase Family of Laser Systems, Candela Corp. (2003) Summary page 1.
- K024335: Candela Gentlelase Family of Laser Systems, Candela Corp. (2003) Summary page 1.
- K994260: Candela Gentlelase GL Dermatological Laser, Candela Corp. (2000) 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.

## Most influential descendants
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K090571: Alma Lasers ALEX755 Module (2009), 58 descendants of its own

## Indications for use
1. The ARION Alexandrite Laser is intended for use in dermatology for hair removal for skin types Fitzpatrick I - IV.

Source page: https://510kreport.com/device/K042474
Methodology: https://510kreport.com/methodology