# K080496: Mosaic ECO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Jul 7, 2008 after 136 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: 12 generations back to K910422 (1992). 150 ancestors in all.
30 later devices descend from it; 4 cite it directly.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 1.
- K933918: Sharplan Model 1080S CO2 Surgical Laser, Sharplan Lasers, Inc. (1994) Summary page 1.
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers, Lumenis, Ltd. (2003)
- K071051: Fraxel Iii SR Laser System and Accessories, Reliant Technologies, Inc. (2007) Summary page 1.
- K031224: Smartxide, Cynosure, Inc. (2003) Summary page 1.

## Most influential descendants
- K091115: ECO2 Laser System (2009), 27 descendants of its own
- K123573: Youlaser CO2 Laser (2013), 19 descendants of its own
- K160312: Fraxis Duo (2016), 14 descendants of its own
- K170325: Secret RF (2017), 10 descendants of its own
- K210084: Silkro (2022), 3 descendants of its own

## Indications for use
The MOSAIC eCO2 is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.

Source page: https://510kreport.com/device/K080496
Methodology: https://510kreport.com/methodology