510(k) · Cleared
ClearedTattoostar Effect 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 May 11, 2012 as substantially equivalent to K071451 (Asclepion Laser Technologies GmbH, 2007) and 4 other predicates after a 240-day review. Its family tree reaches back 13 generations to 1995. 8 later devices descend from it.
- Decided
- May 11, 2012
- Review
- 240 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K943450 (1995). 190 ancestors in all, the oldest K800617 (1980). 8 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 1 generation backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- This deviceK112669 Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012
- Descendant · cites it directly · 6 of its ownK173692 D-Actor 200 Vibration Massage SystemStorz Medical AG · 2018
- Descendant · 2 generations on · 2 of its ownK210451 OrthoGold 100Tissue Regeneration Technologies, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK220538 DolorClast RadialE.M.S Electro Medical Systems S.A · 2022
- Descendant · 2 generations on · 0 of its ownK243488 Vmat ProTermosalud · 2025
- Descendant · 2 generations on · 0 of its ownK221865 BTL-094BTL Industries, Inc. · 2023
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 8 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 7 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 6 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 5 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 1 generation backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- This deviceK112669 Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173692D-Actor 200 Vibration Massage SystemStorz Medical AG · 2018 · cites it directly6descendants
- K210451OrthoGold 100Tissue Regeneration Technologies, LLC · 2021 · 2 generations on2descendants
- K220538DolorClast RadialE.M.S Electro Medical Systems S.A · 2022 · 2 generations on1descendant
- K243488Vmat ProTermosalud · 2025 · 2 generations on0descendants
- K221865BTL-094BTL Industries, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −8 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −7 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −6 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −5 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −3 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −2 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −1 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| 0 (this device) | K112669 | Tattoostar Effect Y | Asclepion Laser Technologies GmbH | 2012 | — |
| +1 | K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | 2018 | — |
| +2 | K210451 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2021 | — |
| +2 | K220538 | DolorClast Radial | E.M.S Electro Medical Systems S.A | 2022 | — |
| +2 | K243488 | Vmat Pro | Termosalud | 2025 | — |
| +2 | K221865 | BTL-094 | BTL Industries, Inc. | 2023 | — |
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 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K071451 | Tattoostar YSummary page 1…surgery and in dermatology 79-GEX 21 CFR 878.4810 Equivalent Devices: TattooStar Y K071 451 Spectra K103455 Dermablate Effect K081541… | 2007 |
| * | K103455 | Spectra Laser SystemSummary page 1…79-GEX 21 CFR 878.4810 Equivalent Devices: TattooStar Y K071 451 Spectra K103455 Dermablate Effect K081541 Aluma K051214… | 2011 |
| * | K081541 | Dermablate EffectSummary page 1…878.4810 Equivalent Devices: TattooStar Y K071 451 Spectra K103455 Dermablate Effect K081541 Aluma K051214 Ellipse Flex PIPT K052688 Device Descripti… | 2009 |
| * | K051214 | Aluma Skin Renewal SystemSummary page 1…K071 451 Spectra K103455 Dermablate Effect K081541 Aluma K051214 Ellipse Flex PIPT K052688 Device Description: The TattooStar Effect Y is a pulsed Nd:YAG sol… | 2005 |
| * | K052688 | Ellipse Flex PPT, Model 9ESF7255Summary page 1…K103455 Dermablate Effect K081541 Aluma K051214 Ellipse Flex PIPT K052688 Device Description: The TattooStar Effect Y is a pulsed Nd:YAG solid state laser emitting wavele… | 2005 |
What descends from it? (8)
2 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?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 8 of the 190 ancestors have a recall of any class.
- Of its descendants, K173692 (Storz Medical AG, 2018) has gone furthest, with 6 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. 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?
The TattooStar Effect Y laser is indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and unwanted hair and skin resurfacing procedures. Depending on the wavelength selected, the indications are as follows: 1064 nm:. Removal of black and blue tattoo color Removal of unwanted hair Skin resurfacing 532 nm: Removal of pigmented lesions (including but…
Read the full statement (235 words)
The TattooStar Effect Y laser is indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and unwanted hair and skin resurfacing procedures.
Depending on the wavelength selected, the indications are as follows:
1064 nm:. Removal of black and blue tattoo color
Removal of unwanted hair
Skin resurfacing
532 nm: Removal of pigmented lesions (including but not limited to lentigo benigna, hyperpigmented burn and boil scar, naevus Ota / Ito, freckles, Becker naevi, Cafo au-lait spots)
Removal of red tattoo color
Removal of minor vascular lesions
585 nm: Removal of sky blue tattoo color
The Asciepion Pulsed Light of the TattooStar Effect Y is intended for permanent hair reduction, treatment of vascular lesions, pigmented lesions and inflammatory acne.
Depending on the different filters, the indications are as follows:
400 -750 nm: Acne
500 - 1200 nm: Hair removal of blond hair, skin type 1-11
Vascular lesions, skin type 1-11
550 -1200 nm: Hair removal of brown and black hair, skin type 1-11
Hair removal of blond, brown and black hair, skin type Ill
Vascular lesions, skin type II-IV
Pigmented lesions, skin type I-IV
650 - 1200 nm: Hair removal of black hair, skin type IV
The Radiofrequency is intended for dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids.
The Acoustic Wave is intended for the activation of connective tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112669: Tattoostar Effect Y.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112669
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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