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 Nov 19, 2020 as substantially equivalent to K171227 (Fotona D.O.O., 2017) and 5 other predicates after a 108-day review. Its family tree reaches back 26 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 19, 2020
- Review
- 108 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 26 generations to K943450 (1995). 566 ancestors in all, the oldest K771218 (1978). 3 later devices descend from it, 2 citing it directly.
- Root · 26 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations between
- 3 generations backK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 2 generations backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 1 generation backK191685 PicoWay Laser SystemCandela Corporation · 2019
- This deviceK202172 StarWalkerFotona D.O.O. · 2020
- Descendant · cites it directly · 1 of its ownK253342 PICO-KSpeclipse, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261214 Pico Shining (Pico-K; Picofy)Speclipse, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253344 Bellus-QSpeclipse, Inc. · 2025
Show all 26 generations
- Root · 26 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 25 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 24 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 22 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 21 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 20 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 19 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 18 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 17 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 15 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 14 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 13 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 12 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 11 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 10 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 9 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 8 generations backK133364 Picosure WorkstationCynosure, Inc. · 2014
- 7 generations backK140719 Picosure WorkstationCynosure, Inc. · 2014
- 6 generations backK143105 Picosure WorkstationCynosure, Inc. · 2015
- 5 generations backK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 4 generations backK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 3 generations backK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 2 generations backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 1 generation backK191685 PicoWay Laser SystemCandela Corporation · 2019
- This deviceK202172 StarWalkerFotona D.O.O. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −25 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −24 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −22 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −21 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −20 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −19 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −18 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −17 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −15 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −14 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −13 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −12 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −11 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −10 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −9 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −8 | K133364 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −7 | K140719 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −6 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| −5 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −4 | K160607 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −3 | K162454 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| −2 | K170597 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| −1 | K191685 | PicoWay Laser System | Candela Corporation | 2019 | — |
| 0 (this device) | K202172 | StarWalker | Fotona D.O.O. | 2020 | — |
| +1 | K253342 | PICO-K | Speclipse, Inc. | 2025 | — |
| +2 | K261214 | Pico Shining (Pico-K; Picofy) | Speclipse, Inc. | 2026 | — |
| +1 | K253344 | Bellus-Q | Speclipse, Inc. | 2025 | — |
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 | 29 | 0 |
| 2000 | 36 | 0 |
| 2001 | 35 | 0 |
| 2002 | 42 | 0 |
| 2003 | 47 | 0 |
| 2004 | 35 | 0 |
| 2005 | 27 | 0 |
| 2006 | 19 | 0 |
| 2007 | 19 | 0 |
| 2008 | 20 | 0 |
| 2009 | 10 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 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? (6)
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 |
|---|---|---|---|
| * | K171227 | StarWalkerSummary page 5…y Classification name: GEX-Powered Laser Surgical Instrument 21 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICES StarWalker (K171227) Fotona QX ND:YAG/KTP Laser System Family (K083889) Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) PicoWay Las… | 2017 |
| * | K083889 | Fotona QX ND:Yag/KTP Laser System FamilySummary page 5…Instrument 21 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICES StarWalker (K171227) Fotona QX ND:YAG/KTP Laser System Family (K083889) Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) PicoWay Laser System (K191685) PicoSure Workstation (K173199)… | 2009 |
| * | K011939 | Fotona Dualis, Fotona Dualis PlusSummary page 5…ct Code: GEX PREDICATE DEVICES StarWalker (K171227) Fotona QX ND:YAG/KTP Laser System Family (K083889) Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) PicoWay Laser System (K191685) PicoSure Workstation (K173199) SPECTRA Laser System (K113588) DEVICE DESCRIPTION SUMMARY The F… | 2001 |
| * | K191685 | PicoWay Laser SystemSummary page 5…E DEVICES StarWalker (K171227) Fotona QX ND:YAG/KTP Laser System Family (K083889) Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) PicoWay Laser System (K191685) PicoSure Workstation (K173199) SPECTRA Laser System (K113588) DEVICE DESCRIPTION SUMMARY The Fotona StarWalker Laser System F… | 2019 |
| * | K173199 | PicoSure WorkstationSummary page 5…Fotona QX ND:YAG/KTP Laser System Family (K083889) Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) PicoWay Laser System (K191685) PicoSure Workstation (K173199) SPECTRA Laser System (K113588) DEVICE DESCRIPTION SUMMARY The Fotona StarWalker Laser System Family is based on the previousl… | 2018 |
| * | K113588 | Spectra Laser SystemSummary page 5…em Family (K083889) Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) PicoWay Laser System (K191685) PicoSure Workstation (K173199) SPECTRA Laser System (K113588) DEVICE DESCRIPTION SUMMARY The Fotona StarWalker Laser System Family is based on the previously cleared Fotona StarWalker Las… | 2012 |
What descends from it? (3)
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 25 years and passes through 12 companies; a new generation was cleared every 10 months on median.
- 28 of the 566 ancestors have a recall of any class.
- Of its descendants, K253342 (Speclipse, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K171227.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 StarWalker Laser System Family is indicated 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 -Treatment of melasma -General dermatology indications: Incision, excision, ablation and vaporization of soft tissue 1064 nm wavelength in long pulse…
Read the full statement (411 words)
The StarWalker Laser System Family is indicated 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
-Treatment of melasma
-General dermatology indications: Incision, excision, ablation and vaporization of soft tissue
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
-Removal of epidermal pigmented lesions
532 nm wavelength in long pulse mode:
-Incision, ablation vaporization, coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, subcutaneoous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
-The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia)
1064 nm wavelength in PICO mode:
-Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple
-Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
-Treatment of acne scars in Fitzpatrick Skin Types II‐V
-Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I‐IV
532 nm wavelength in PICO mode:
-Tattoo removal in Skin Types I - III
-Treatment of benign pigmented lesions in Fitzpatrick Skin Types I‐IV
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202172: StarWalker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202172
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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