# K051214: Aluma Skin Renewal System

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Oct 24, 2005 after 165 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943450 (1995). 84 ancestors in all.
476 later devices descend from it; 7 cite it directly.
0 of 561 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033942: Thermage Thermacool System, Thermage, Inc. (2004) Summary page 1.
- K040135: Thermage Thermacool System, Thermage, Inc. (2004) Summary page 1.
- K031671: Polaris WR, Syneron Medical, Ltd. (2003) Summary page 1.

## Most influential descendants
- K060448: Lumenis One Family of Systems; Lumenis One. (2006), 297 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K070004: Accent (2007), 181 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own

## Indications for use
The Aluma Skin Renewal System is intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of wrinkles and rhytids.

Source page: https://510kreport.com/device/K051214
Methodology: https://510kreport.com/methodology