# K123168: Q-Plus T+ Ipl Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Dec 20, 2012 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: 9 generations back to K910422 (1992). 105 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073549: Q-Plus T, Quanta System Spa (2008) Summary page 1.
- K083207: Ultrawave Iii EX 1320, Quanta System Spa (2008) Summary page 2.

## Most influential descendants
- K130256: MDK Multi-Applications Platform (2013), 38 descendants of its own
- K152012: EVO platform (2015), 37 descendants of its own
- K160368: EVO platform (2016), 36 descendants of its own
- K163222: Discovery Pico Family (2016), 30 descendants of its own
- K171945: Discovery Pico, Discovery Pico Plus (2017), 21 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
These wavelengths are absorbed by natural chromophores, like melanin, hemoglobin and water and by exogen pigments like tattoo ink. They are indicated for: Tattoo removal: 1064nm: suggested for dark blue and black ink 532nm: suggested for red, orange, yellow, and purple ink Pigmented lesion removal (benign): Cafe au lait spot Ephalides, solar lentigo (lentigines) Becker Nevus Ota Nevus Nevus spilus This wavelength is absorbed by natural chromophores, like melanin, hemoglobin and water and by exogen pigments like tattoo ink. It is indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink Pigmented lesion removal (benign): Cafe au lait spot Ephalides, solar lentigo (lentigines) Becker Nevus Ota and Ito Nevus Nevus spilus Mongolian spot Indicated for hair removal Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions Indicated for face vascular lesions and solar lentigines (benign pigmented lesions) Indicated for inflammatory acne (acne vulgaris)

Source page: https://510kreport.com/device/K123168
Methodology: https://510kreport.com/methodology