510(k) · Cleared
Recalled · Class II · 2012Q-Plus T
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 Feb 28, 2008 as substantially equivalent to K050382 (Cynosure, Inc., 2005) and 1 other predicate after a 72-day review. Its family tree reaches back 1 generation to 2005. 76 later devices descend from it. It has been recalled once.
- Decided
- Feb 28, 2008
- Review
- 72 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K050382 (2005). 2 ancestors in all. 76 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK050382 Affinity QS Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2005
- This deviceK073549 Q-Plus TQuanta System Spa · 2008
- Descendant · cites it directly · 47 of its ownK140727 Cutera Picosecond Laser SystemCutera, Inc. · 2014
- Descendant · 2 generations on · 41 of its ownK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- Descendant · cites it directly · 40 of its ownK123168 Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · Recalled
- Descendant · cites it directly · 38 of its ownK130256 MDK Multi-Applications PlatformQuanta System Spa · 2013
- Descendant · 2 generations on · 37 of its ownK152012 EVO platformQuanta System Spa · 2015
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K140727Cutera Picosecond Laser SystemCutera, Inc. · 2014 · cites it directly47descendants
- K153527PicoWay Laser SystemSyneron Candela Corporation · 2016 · 2 generations on41descendants
- K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · cites it directly40descendants
- K130256MDK Multi-Applications PlatformQuanta System Spa · 2013 · cites it directly38descendants
- K152012EVO platformQuanta System Spa · 2015 · 2 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050382 | Affinity QS Q-Switched ND:Yag Laser System | Cynosure, Inc. | 2005 | — |
| 0 (this device) | K073549 | Q-Plus T | Quanta System Spa | 2008 | — |
| +1 | K140727 | Cutera Picosecond Laser System | Cutera, Inc. | 2014 | — |
| +2 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| +1 | K123168 | Q-Plus T+ Ipl Laser System | Quanta System Spa | 2012 | 1 |
| +1 | K130256 | MDK Multi-Applications Platform | Quanta System Spa | 2013 | — |
| +2 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 3 | 0 |
| 2024 | 10 | 0 |
| 2025 | 13 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K050382 | Affinity QS Q-Switched ND:Yag Laser SystemSummary page 1…n Instrument, surgical, powered, laser Name: Predicate Devices: - Cynosure, Inc Affinity QS Q-Switched Nd:YAG Laser System (K050382); - ASCLEPION LASER TECHNOLOGIES GmbH TattooStar R (K060787) Intended U… | 2005 |
| * | K060787 | Tattoostar FamilySummary page 1…hed Nd:YAG Laser System (K050382); - ASCLEPION LASER TECHNOLOGIES GmbH TattooStar R (K060787) Intended Use / Nd:YAG (1064nm) and (532nm) Indications for Use: The Q-Plus T Q-Switched laser i… | 2006 |
What descends from it? (76)
See all 765 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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073549: Q-Plus T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073549
Report an extraction error
Are you the manufacturer?
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