510(k) · Cleared
ClearedTattoostar Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asclepion Laser Technologies GmbH · GEX Powered Laser Surgical Instrument
Cleared on Sep 27, 2006 after a 188-day review. The FDA summary names its predicate without a number. 78 later devices descend from it.
- Decided
- Sep 27, 2006
- Review
- 188 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
78 later devices descend from it, 2 citing it directly.
- This deviceK060787 Tattoostar FamilyAsclepion Laser Technologies GmbH · 2006
- Descendant · cites it directly · 76 of its ownK073549 Q-Plus TQuanta System Spa · 2008 · Recalled
- Descendant · 2 generations on · 47 of its ownK140727 Cutera Picosecond Laser SystemCutera, Inc. · 2014
- Descendant · 3 generations on · 41 of its ownK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- Descendant · 2 generations on · 40 of its ownK123168 Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · Recalled
- Descendant · 2 generations on · 38 of its ownK130256 MDK Multi-Applications PlatformQuanta System Spa · 2013
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K073549Q-Plus TQuanta System Spa · 2008 · cites it directly76descendants
- K140727Cutera Picosecond Laser SystemCutera, Inc. · 2014 · 2 generations on47descendants
- K153527PicoWay Laser SystemSyneron Candela Corporation · 2016 · 3 generations on41descendants
- K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · 2 generations on40descendants
- K130256MDK Multi-Applications PlatformQuanta System Spa · 2013 · 2 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060787 | Tattoostar Family | Asclepion Laser Technologies GmbH | 2006 | — |
| +1 | K073549 | Q-Plus T | Quanta System Spa | 2008 | 1 |
| +2 | K140727 | Cutera Picosecond Laser System | Cutera, Inc. | 2014 | — |
| +3 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| +2 | K123168 | Q-Plus T+ Ipl Laser System | Quanta System Spa | 2012 | 1 |
| +2 | K130256 | MDK Multi-Applications Platform | Quanta System Spa | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | — | RubyStar Named without a submission number |
What descends from it? (78)
See all 782 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K073549 (Quanta System Spa, 2008) has gone furthest, with 76 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The TattooStar R 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, BenignNaevi such as Naevus of Ota, Naevus of Ito, Epidermal Naevi, Congenital Naevi, Beckers Naevi, Blue Nevus, Naevus Spillus and Mongolian Spot.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060787: Tattoostar Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060787
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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