510(k) · Cleared
Recalled · Class II · 2012Q-Plus T+ Ipl Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quanta System Spa · GEX Powered Laser Surgical Instrument
Cleared on Dec 20, 2012 as substantially equivalent to K073549 (Quanta System Spa, 2008) and 1 other predicate after a 72-day review. Its family tree reaches back 9 generations to 1992. 40 later devices descend from it. It has been recalled once.
- Decided
- Dec 20, 2012
- Review
- 72 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K910422 (1992). 105 ancestors in all, the oldest K820106 (1982). 40 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 2 generations backK032218 Adept 1064/532/755 LaserAdept Medical Concepts · 2003
- 1 generation backK083207 Ultrawave Iii EX 1320Quanta System Spa · 2008 · Recalled
- This deviceK123168 Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012
- Descendant · cites it directly · 38 of its ownK130256 MDK Multi-Applications PlatformQuanta System Spa · 2013
- Descendant · cites it directly · 37 of its ownK152012 EVO platformQuanta System Spa · 2015
- Descendant · 2 generations on · 36 of its ownK160368 EVO platformQuanta System Spa · 2016
- Descendant · 3 generations on · 30 of its ownK163222 Discovery Pico FamilyQuanta System Spa · 2016
- Descendant · 4 generations on · 21 of its ownK171945 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 3 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 2 generations backK032218 Adept 1064/532/755 LaserAdept Medical Concepts · 2003
- 1 generation backK083207 Ultrawave Iii EX 1320Quanta System Spa · 2008 · Recalled
- This deviceK123168 Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K130256MDK Multi-Applications PlatformQuanta System Spa · 2013 · cites it directly38descendants
- K152012EVO platformQuanta System Spa · 2015 · cites it directly37descendants
- K160368EVO platformQuanta System Spa · 2016 · 2 generations on36descendants
- K163222Discovery Pico FamilyQuanta System Spa · 2016 · 3 generations on30descendants
- K171945Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −3 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| −2 | K032218 | Adept 1064/532/755 Laser | Adept Medical Concepts | 2003 | — |
| −1 | K083207 | Ultrawave Iii EX 1320 | Quanta System Spa | 2008 | 1 |
| 0 (this device) | K123168 | Q-Plus T+ Ipl Laser System | Quanta System Spa | 2012 | — |
| +1 | K130256 | MDK Multi-Applications Platform | Quanta System Spa | 2013 | — |
| +1 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| +2 | K160368 | EVO platform | Quanta System Spa | 2016 | — |
| +3 | K163222 | Discovery Pico Family | Quanta System Spa | 2016 | — |
| +4 | K171945 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 10 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 12 | 0 |
| 2002 | 13 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 11 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073549 | Q-Plus TSummary page 1…GEX Predicate Devices: The 0-Plus T + IPL Laser System is claimed to be substantially equivalent to the following legally marketed predicate devices: * K073549 0-Plus T manufactured by Quanta System SPA * K<083207 Ultrawave IIl EX 1320 manufactured by Quanta System SPA Performa… | 2008 |
| * | K083207 | Ultrawave Iii EX 1320Summary page 2…IPL laser system contain all nine subsystems of the 0-Plus T (K073549) with the addition of the IPL hand piece subsystem that is cleared with the Ultrawave Ill EX 1320 (K083207). The a-Switched Nd:YAG laser source with a max energy of lOOOmJ at 1064nm and a max energy of 500mJ at 532nm is identical to the… | 2008 |
| † | K051113 | Quanta System Etrna Giovinezza | 2006 |
What descends from it? (40)
See all 403 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2012 | Class II | Z-0691-2013 | Labeling False and Misleading | 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 therein were not meant to apply to the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 105 ancestors have a recall of any class.
- Of its descendants, K130256 (Quanta System Spa, 2013) has gone furthest, with 38 descendants of its own.
- 4 other devices also cite its predicate K073549.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (164 words)
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123168: Q-Plus T+ Ipl Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123168
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026