510(k) · Cleared
ClearedTattoostar Effect Combo
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 Jul 17, 2014 as substantially equivalent to K112669 (Asclepion Laser Technologies GmbH, 2012) and 1 other predicate after a 395-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Jul 17, 2014
- Review
- 395 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K943450 (1995). 192 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 1 generation backK112669 Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012
- This deviceK131757 Tattoostar Effect ComboAsclepion Laser Technologies GmbH · 2014
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 1 generation backK112669 Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012
- This deviceK131757 Tattoostar Effect ComboAsclepion Laser Technologies GmbH · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −2 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −1 | K112669 | Tattoostar Effect Y | Asclepion Laser Technologies GmbH | 2012 | — |
| 0 (this device) | K131757 | Tattoostar Effect Combo | Asclepion Laser Technologies GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 5 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 16 | 0 |
| 1997 | 18 | 0 |
| 1998 | 11 | 0 |
| 1999 | 7 | 0 |
| 2000 | 18 | 0 |
| 2001 | 14 | 0 |
| 2002 | 22 | 0 |
| 2003 | 13 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K112669 | Tattoostar Effect YSummary page 1…and in dermatology 79-GEX 21 CER 878.4810 Equivalent Devices: TattooStar Effect Y K1 12669 TattooStar R K060787 Device Description: The TattooStar Effect Combo is a combinat… | 2012 |
| * | K060787 | Tattoostar FamilySummary page 1…79-GEX 21 CER 878.4810 Equivalent Devices: TattooStar Effect Y K1 12669 TattooStar R K060787 Device Description: The TattooStar Effect Combo is a combination of a Nd:YAG laser and a Ruby l… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 8 of the 192 ancestors have a recall of any class.
- 1 other device also cites its predicate K112669.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Effect Combo is indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and skin resurfacing procedures. Depending on the wavelength selected, the indications are as follows: 1064 nm: Removal of black and blue tattoo color 3-3.5 J/cmA2, 2-4 mm, 1-10Hz, 8 ns Skin resurfacing 1.5-2.5 J/cnr2, 5.5 mm, 10 Hz, 0.3 ms 1.5 J/cmA2, 7 mm, 2-5…
Read the full statement (163 words)
The TattooStar Effect Combo is indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and skin resurfacing procedures. Depending on the wavelength selected, the indications are as follows:
1064 nm: Removal of black and blue tattoo color 3-3.5 J/cmA2, 2-4 mm, 1-10Hz, 8 ns
Skin resurfacing 1.5-2.5 J/cnr2, 5.5 mm, 10 Hz, 0.3 ms
1.5 J/cmA2, 7 mm, 2-5 Hz, 8 ns
532 rn: Removal of pigmented lesions (including but not limited to lentigo benigna, hyperpigmented bum and boil scar, naevus Ota / Ito, freckles, Becker naevi, Cafe-au-Iait spots) 2-2.5 J/CMA 2 4mm, 1-5H-1, 8 ns
Removal of red tattoo color 2 J/cmA2, 4mm, I-5Hz, Sns
585 nm: Removal of sky blue tattoo color 2-3 J/CMA 2, 2.5mm, I-5Hz, 8 ns
694nm: Removal of pigmented lesions 3 J/cmA2, 4-5.5 mm, 0.5-2 Hz, 40 ns
Removal of black, blue and green tattoo color 2-3 J/cmA2, 4-5.5 mm, 0.5-2 Hz, 40 ns
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131757: Tattoostar Effect Combo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131757
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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