510(k) · Cleared
ClearedStarWalker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fotona D.O.O. · GEX Powered Laser Surgical Instrument
Cleared on Aug 18, 2017 as substantially equivalent to K083889 (Fotona D.D., 2009) and 2 other predicates after a 114-day review. Its family tree reaches back 21 generations to 1995. 7 later devices descend from it.
- Decided
- Aug 18, 2017
- Review
- 114 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K943450 (1995). 541 ancestors in all, the oldest K771218 (1978). 7 later devices descend from it, 2 citing it directly.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 2 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 1 generation backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- This deviceK171227 StarWalkerFotona D.O.O. · 2017
- Descendant · cites it directly · 3 of its ownK202172 StarWalkerFotona D.O.O. · 2020
- Descendant · cites it directly · 2 of its ownK202288 FinebeamSNJ Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK253342 PICO-KSpeclipse, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK261214 Pico Shining (Pico-K; Picofy)Speclipse, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260256 Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd. · 2026
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 8 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 7 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 6 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 4 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 3 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 2 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 1 generation backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- This deviceK171227 StarWalkerFotona D.O.O. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K202172StarWalkerFotona D.O.O. · 2020 · cites it directly3descendants
- K202288FinebeamSNJ Co., Ltd. · 2021 · cites it directly2descendants
- K253342PICO-KSpeclipse, Inc. · 2025 · 2 generations on1descendant
- K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc. · 2026 · 3 generations on0descendants
- K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −8 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −7 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −6 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −4 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −2 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −1 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| 0 (this device) | K171227 | StarWalker | Fotona D.O.O. | 2017 | — |
| +1 | K202172 | StarWalker | Fotona D.O.O. | 2020 | — |
| +1 | K202288 | Finebeam | SNJ Co., Ltd. | 2021 | — |
| +2 | K253342 | PICO-K | Speclipse, Inc. | 2025 | — |
| +3 | K261214 | Pico Shining (Pico-K; Picofy) | Speclipse, Inc. | 2026 | — |
| +2 | K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 9 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 27 | 0 |
| 1995 | 26 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 33 | 0 |
| 1999 | 28 | 0 |
| 2000 | 36 | 0 |
| 2001 | 35 | 0 |
| 2002 | 42 | 0 |
| 2003 | 47 | 0 |
| 2004 | 34 | 0 |
| 2005 | 28 | 0 |
| 2006 | 17 | 0 |
| 2007 | 17 | 0 |
| 2008 | 19 | 0 |
| 2009 | 10 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K083889 | Fotona QX ND:Yag/KTP Laser System FamilySummary page 5…Surgery 21 CFR 878.4810, Class II Product Code: GEX 5.3 PREDICATE DEVICES • Fotona QX ND:YAG/KTP Laser System Family (K083889) • Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) • Fotona Dynamis Pro Family (K143723)… | 2009 |
| * | K011939 | Fotona Dualis, Fotona Dualis PlusSummary page 5…t Code: GEX 5.3 PREDICATE DEVICES • Fotona QX ND:YAG/KTP Laser System Family (K083889) • Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) • Fotona Dynamis Pro Family (K143723) 510(k) Submission: Fotona StarWalker Laser System Family… | 2001 |
| * | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroSummary page 5…• Fotona QX ND:YAG/KTP Laser System Family (K083889) • Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) • Fotona Dynamis Pro Family (K143723) 510(k) Submission: Fotona StarWalker Laser System Family 17/68 5.4 DEVICE DESCRIPTI… | 2015 |
What descends from it? (7)
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 22 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 26 of the 541 ancestors have a recall of any class.
- Of its descendants, K202172 (Fotona D.O.O., 2020) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K083889.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Fotona StarWalker Laser System Family, and its accessories, are intended for: 1064 nm wavelength in Q-switched mode: – Removal of dark (black, blue, brown) tattoo ink – Treatment of nevus of ota – Treatment of common nevi – Removal and lightening of unwanted hair – Skin resurfacing procedures for the treatment of acne scars and wrinkles 1064 nm wavelength in long pulse mode: – Removal of unwanted hair, for stable long term or permanent hair reduction…
Read the full statement (309 words)
The Fotona StarWalker Laser System Family, and its accessories, are intended for:
1064 nm wavelength in Q-switched mode:
– Removal of dark (black, blue, brown) tattoo ink
– Treatment of nevus of ota
– Treatment of common nevi
– Removal and lightening of unwanted hair
– Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064 nm wavelength in long pulse mode:
– Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
– Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to,
– port wine stains,
– hemaongiomae,
– warts,
– telangiectasiae,
– rosacea,
– venus lake,
– leg veins and
– spider veins
– Coagulation and hemostasis of soft tissue
– Treatment of wrinkles
– Treatment of mild to moderate inflammatory acne vulgaris
532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):
– Red, tan, purple and orange tattoo ink removal
– Sky blue (light) tattoo ink removal
– Green tattoo tattoo ink removal
– Treatment of benign pigmented lesions including, but not limited to:
– cafe-au-lait birthmarks
– solar lentigines
– senile lentigines
– senile lentigines
– Becker's nevi
– freckles
– common nevi
– nevus spilus
– Treatment of benign vascular lesion including, but not limited to:
– port wine birthmarks
– telangiectasias
– spider angioma
– cherry angioma
– spider nevi
– Seborrheic Keratosis
– Treatment of post-inflammatory hyperpigmentation
– Skin resurfacing procedures for the treatment of acne scars and wrinkles
532 nm wavelength in long pulse mode:
– The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171227: StarWalker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171227
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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