510(k) · Cleared
ClearedLightWalker Laser System Family
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 23, 2024 as substantially equivalent to K202985 (Fotona D.O.O., 2021) after a 28-day review. Its family tree reaches back 24 generations to 1995. 1 later device descends from it.
- Decided
- Aug 23, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 24 generations to K943450 (1995). 568 ancestors in all, the oldest K771218 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations between
- 3 generations backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- 2 generations backK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- 1 generation backK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- This deviceK242202 LightWalker Laser System FamilyFotona D.O.O. · 2024
- Descendant · cites it directly · 0 of its ownK253309 SOGA Lasers therapy system family of Aurora handpiece (Aurora-S)…Shenzhen Soga Technology Co., Ltd. · 2026
Show all 24 generations
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 20 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 19 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 18 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 17 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 16 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 13 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 12 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 11 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 10 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 9 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 8 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 7 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 6 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 5 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 4 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 3 generations backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- 2 generations backK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- 1 generation backK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- This deviceK242202 LightWalker Laser System FamilyFotona D.O.O. · 2024
Most influential descendants
Showing 1 of 1 · See all- K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −23 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −20 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −19 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −18 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −17 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −16 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −13 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −12 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −11 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −10 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −9 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −8 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −7 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −6 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −5 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −4 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −3 | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | 2018 | — |
| −2 | K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020 | — |
| −1 | K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021 | — |
| 0 (this device) | K242202 | LightWalker Laser System Family | Fotona D.O.O. | 2024 | — |
| +1 | K253309 | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers… | Shenzhen Soga 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 | 35 | 0 |
| 1999 | 28 | 0 |
| 2000 | 38 | 0 |
| 2001 | 35 | 0 |
| 2002 | 42 | 0 |
| 2003 | 48 | 0 |
| 2004 | 36 | 0 |
| 2005 | 32 | 0 |
| 2006 | 18 | 0 |
| 2007 | 17 | 0 |
| 2008 | 21 | 0 |
| 2009 | 13 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K202985 | LightWalker Laser System FamilySummary page 7…Product Code: GEX Panel: General and Plastic Surgery 3. PREDICATE DEVICEIDENTIFICATION K202985 LightWalker Laser System Family 4. DEVICE DESCRIPTION: The Fotona LightWalker Laser System Family is… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253309 | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy… | 2026 | 0 |
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 29 years and passes through 9 companies; a new generation was cleared every 12 months on median.
- 29 of the 568 ancestors have a recall of any class.
- Of its descendants, K253309 (Shenzhen Soga Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K202985.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Er:YAG laser (2940 nm wavelength) in dentistry: • Intra-oral soft tissue surgery (incision, excision, ablation, coagulation); • Leukoplakia; • Pulpotomy as adjunct to root canal retreatment; • Pulp extirpation; • Removal of fibromae; • Removal of granulated tissue; • Caries removal, cavity preparation, enamel roughening; • Sulcular debridement; • Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation…
Read the full statement (918 words)
Er:YAG laser (2940 nm wavelength) in dentistry:
• Intra-oral soft tissue surgery (incision, excision, ablation, coagulation);
• Leukoplakia;
• Pulpotomy as adjunct to root canal retreatment;
• Pulp extirpation;
• Removal of fibromae;
• Removal of granulated tissue;
• Caries removal, cavity preparation, enamel roughening;
• Sulcular debridement;
• Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement;
• Cutting, shaving, contouring and resection of oral osseous tissue (bone);
• Osteotomy, osseous crown lengthening, osteoplasty;
• Apicectomy surgery;
• Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage;
• Laser removal of porcelain and ceramic crowns and veneers;
• Flap preparation – incision of soft-tissue to prepare a flap and expose the bone;
• Cutting bone to prepare a window access to the apex (apices) of the root(s);
• Root-end preparation for retrofill amalgam or composite;
• Full thickness flap;
• Partial thickness flap;
• Split thickness flap;
• Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket;
• Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium;
• Excisional and incisional biopsies;
• Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions);
• Frenectomy and frenotomy;
• Gingival troughing for crown impressions;
• Gingivectomy;
• Gingivoplasty;
• Implant recovery;
• Root canal debridement and cleaning;
• Soft tissue crown lengthening;
• Laser root canal disinfection after endodontic treatment;
Er:YAG laser (2940 nm wavelength) in dermatology and other surgical areas:
The LightWalker Er:YAG laser is intended for surgical incision/excision, cutting, ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
• Dermatology and Plastic Surgery Indications: epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing;
• ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
• Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy;
• Uvulopalatoplasty by laser resurfacing
• General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation;
• Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;
• Ophtalmology Indications: Soft tissue surrounding the eye;
• Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;
• Genitourinary Indications: Lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon;
• Dermatological procedures requiring resurfacing of soft tissue with Fotona FS-01 fractionated handpiece.
Nd:YAG laser (1064 nm wavelength) in dentistry:
• Excisional and incisional biopsies;
• Excision and vaporization of herpes simplex I and II;
• Exposure of unerupted teeth;
• Fibroma removal;
• Frenectomy and frenotomy;
• Gingival troughing for crown impressions;
• Gingivectomy;
• Gingivoplasty;
• Gingival incision and excision;
• Hemostasis;
• Implant recovery;
• Incision and drainage of abscess;
• Laser assisted uvulopaletoplasty (LAUP);
• Operculectomy;
• Oral papillectomies;
• Pulpotomy and pulpotomy as an adjunct to root canal therapy;
• Reduction of denture hyperplasia;
• Reduction of gingival hypertrophy;
• Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;
• Removal of post-surgical granulations;
• Soft tissue crown lengthening;
• Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and toothmobility);
• Tissue retraction for impression;
• Treatment of aphtous ulcers;
• Vestibuloplasty;
• Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium);
• Periodontal regeneration – true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface.
Nd:YAG laser (1064 nm wavelength) in dermatology and other surgical areas:
• 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 pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins;
• Treatment of wrinkles;
• Treatment of mild to moderate inflammatory acne vulgaris;
• General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal;
• Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas;
• Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.);
• Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.
Nd:YAG laser (1064 nm wavelength) therapy:
• Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.
*Note: Permanent hair reduction is defined as the long-term, stable redction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242202 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242202: LightWalker Laser System Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242202
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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