510(k) · Cleared
ClearedTattoostar Y
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 Aug 1, 2007 after a 69-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Aug 1, 2007
- Review
- 69 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK071451 Tattoostar YAsclepion Laser Technologies GmbH · 2007
- Descendant · cites it directly · 8 of its ownK112669 Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012
- Descendant · 2 generations on · 6 of its ownK173692 D-Actor 200 Vibration Massage SystemStorz Medical AG · 2018
- Descendant · 3 generations on · 2 of its ownK210451 OrthoGold 100Tissue Regeneration Technologies, LLC · 2021
- Descendant · 3 generations on · 1 of its ownK220538 DolorClast RadialE.M.S Electro Medical Systems S.A · 2022
- Descendant · 3 generations on · 0 of its ownK243488 Vmat ProTermosalud · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K112669Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012 · cites it directly8descendants
- K173692D-Actor 200 Vibration Massage SystemStorz Medical AG · 2018 · 2 generations on6descendants
- K210451OrthoGold 100Tissue Regeneration Technologies, LLC · 2021 · 3 generations on2descendants
- K220538DolorClast RadialE.M.S Electro Medical Systems S.A · 2022 · 3 generations on1descendant
- K243488Vmat ProTermosalud · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071451 | Tattoostar Y | Asclepion Laser Technologies GmbH | 2007 | — |
| +1 | K112669 | Tattoostar Effect Y | Asclepion Laser Technologies GmbH | 2012 | — |
| +2 | K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | 2018 | — |
| +3 | K210451 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2021 | — |
| +3 | K220538 | DolorClast Radial | E.M.S Electro Medical Systems S.A | 2022 | — |
| +3 | K243488 | Vmat Pro | Termosalud | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | — | Medlite CE Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112669 | Tattoostar Effect Y | 2012 | 8 |
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, K112669 (Asclepion Laser Technologies GmbH, 2012) has gone furthest, with 8 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. 2007, 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?
The TattooStar Y is intended for use for incision, excision, ablation, vaporization of soft tissue for general dermatology and the removal of tattoos, the removal of benign pigmented lesion, the removal of vascular lesion and the removal of hair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071451: Tattoostar Y.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071451
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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