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 30, 2019 as substantially equivalent to K172819 (Fotona D.O.O., 2017) and 1 other predicate after a 79-day review. Its family tree reaches back 11 generations to 1992. 19 later devices descend from it.
- Decided
- Aug 30, 2019
- Review
- 79 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K910422 (1992). 111 ancestors in all, the oldest K820106 (1982). 19 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations between
- 3 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 2 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 1 generation backK172819 LightWalker Laser System FamilyFotona D.O.O. · 2017
- This deviceK191554 LightWalker Laser System FamilyFotona D.O.O. · 2019
- Descendant · cites it directly · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · cites it directly · 8 of its ownK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- Descendant · 2 generations on · 7 of its ownK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- Descendant · 2 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · 2 generations on · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 7 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 6 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 5 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 4 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 3 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 2 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 1 generation backK172819 LightWalker Laser System FamilyFotona D.O.O. · 2017
- This deviceK191554 LightWalker Laser System FamilyFotona D.O.O. · 2019
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K193656SkyPulseFotona D.O.O. · 2020 · cites it directly11descendants
- K193661LightWalker Laser System FamilyFotona D.O.O. · 2020 · cites it directly8descendants
- K202985LightWalker Laser System FamilyFotona D.O.O. · 2021 · 2 generations on7descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 2 generations on3descendants
- K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −10 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −8 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −7 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −6 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −5 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −4 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −3 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −2 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| −1 | K172819 | LightWalker Laser System Family | Fotona D.O.O. | 2017 | — |
| 0 (this device) | K191554 | LightWalker Laser System Family | Fotona D.O.O. | 2019 | — |
| +1 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +1 | K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020 | — |
| +2 | K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021 | — |
| +2 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +2 | K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 14 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K172819 | LightWalker Laser System FamilySummary page 6…rument, General and Plastic Surgery 21 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICES • LightWalker Laser System Family (K172819) • Hilthera 4.0 Therapeutical Laser System (K141861) DEVICE DESCRIPTION The device is Fotona LightWalker laser system fami… | 2017 |
| * | K141861 | Hilthera 4.0Summary page 6…1 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICES • LightWalker Laser System Family (K172819) • Hilthera 4.0 Therapeutical Laser System (K141861) DEVICE DESCRIPTION The device is Fotona LightWalker laser system family (same as K172819). It is based on Er:YAG (2940 nm) and… | 2015 |
What descends from it? (19)
See all 192 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 27 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 111 ancestors have a recall of any class.
- Of its descendants, K193656 (Fotona D.O.O., 2020) has gone furthest, with 11 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. 2019, 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 (659 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 curetage
Er:YAG laser (2940 nm wavelength) in dermatology and other surgical areas:
* Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing
* ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia
* Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy
* 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
Nd:YAG laser (1064 nm wavelength) in dentistry:
» Excisional and incisional biopsies
» Excision and vaporization of herpes simplex [ 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 tooth mobility)
» 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-V1, 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.)
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 reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191554: LightWalker Laser System Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191554
Report an extraction error
Are you the manufacturer?
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