# K073549: Q-Plus T

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Feb 28, 2008 after 72 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K050382 (2005). 2 ancestors in all.
76 later devices descend from it; 5 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050382: Affinity QS Q-Switched ND:Yag Laser System, Cynosure, Inc. (2005) Summary page 1.
- K060787: Tattoostar Family, Asclepion Laser Technologies GmbH (2006) Summary page 1.

## Most influential descendants
- K140727: Cutera Picosecond Laser System (2014), 47 descendants of its own
- K153527: PicoWay Laser System (2016), 41 descendants of its own
- K123168: Q-Plus T+ Ipl Laser System (2012), 40 descendants of its own
- K130256: MDK Multi-Applications Platform (2013), 38 descendants of its own
- K152012: EVO platform (2015), 37 descendants of its own

## Recalls of this device
- Nov 7, 2012 · Class II · Z-0691-2013: Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made ther

## Indications for use
Nd:YAG (1064nm) and (532nm) The Q-Plus T Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby (694nm) The Q-Plus T Q-Switched laser is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion. Some examples of pigment lesions are * Lentigines * caf6-au-lait-blotches * Ephalides * Benign Naevi such as: * Naevus of Ota * Naevus of Ito * Epidermal Naevi * Congenital Naevi * Beckers Naevi * Blue Nevus * Naevus Spillus * Mongolian Spot

Source page: https://510kreport.com/device/K073549
Methodology: https://510kreport.com/methodology