510(k) Report

510(k) · Cleared

Cleared

LightWalker Laser System Family

K191554510(k) TraditionalCleared Aug 30, 201979-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2016: 1 other ancestor2005: 1 other ancestor2004: 4 other ancestors2003: 6 other ancestors2002: 14 other ancestors2000: 10 other ancestors2001: 10 other ancestors1999: 4 other ancestors1997: 9 other ancestors1996: 8 other ancestors1998: 6 other ancestors1995: 6 other ancestors1994: 8 other ancestors1990: 1 other ancestor1993: 5 other ancestors1991: 4 other ancestors1988: 1 other ancestor1982: 1 other ancestor2020: 2 descendants cleared2022: 3 descendants cleared2023: 2 descendants cleared2025: 4 descendants cleared2024: 3 descendants cleared2021: 2 descendants cleared2026: 3 descendants clearedK910422 · Model RD-1200 Ruby Laser System · Spectrum Medical Technologies, Inc. · 1992K961279 · Sharplan Lasers, Inc. Ruby Laser System · Sharplan Lasers, Inc. · 1996K962446 · Sharplan Ruby Laser System · Sharplan Lasers, Inc. · 1997K974536 · Photoderm HR System · Esc Medical Systems, Ltd. · 1998K991935 · Epilight Hair Removal System, Photoderm HR System · Esc Medical Systems, Ltd. · 2000K014040 · Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models · Altus Medical, Inc. · 2002K023193 · Candela Gentle Yag Laser System · Candela Corp. · 2002K033172 · Candela Gentleyag Family of Laser Systems · Candela Corp. · 2003K050293 · Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of Laser Systems · Fotona D.D. · 2005K070355 · Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family · Fotona D.D. · 2008K172819 · LightWalker Laser System Family · Fotona D.O.O. · 201719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 7 other ancestors4 generations back: 4 other ancestors5 generations back: 32 other ancestors6 generations back: 22 other ancestors7 generations back: 13 other ancestors8 generations back: 5 other ancestors9 generations back: 14 other ancestors 1 generation forward: 2 descendants2 generations forward: 7 descendants3 generations forward: 7 descendants4 generations forward: 3 descendants K172819 · LightWalker Laser System Family · Fotona D.O.O. · 2017K070355 · Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family · Fotona D.D. · 2008K050293 · Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of Laser Systems · Fotona D.D. · 2005K033172 · Candela Gentleyag Family of Laser Systems · Candela Corp. · 2003K023193 · Candela Gentle Yag Laser System · Candela Corp. · 2002K014040 · Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models · Altus Medical, Inc. · 2002K991935 · Epilight Hair Removal System, Photoderm HR System · Esc Medical Systems, Ltd. · 2000K974536 · Photoderm HR System · Esc Medical Systems, Ltd. · 1998K962446 · Sharplan Ruby Laser System · Sharplan Lasers, Inc. · 1997K961279 · Sharplan Lasers, Inc. Ruby Laser System · Sharplan Lasers, Inc. · 1996K910422 · Model RD-1200 Ruby Laser System · Spectrum Medical Technologies, Inc. · 1992−10−50
  1. Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
  2. 7 generations between
  3. 3 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
  4. 2 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
  5. 1 generation backK172819 LightWalker Laser System FamilyFotona D.O.O. · 2017
  6. This deviceK191554 LightWalker Laser System FamilyFotona D.O.O. · 2019
  7. Descendant · cites it directly · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
  8. Descendant · cites it directly · 8 of its ownK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
  9. Descendant · 2 generations on · 7 of its ownK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
  10. Descendant · 2 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
  11. Descendant · 2 generations on · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
Show all 11 generations
  1. Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
  2. 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
  3. 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
  4. 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
  5. 7 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
  6. 6 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
  7. 5 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
  8. 4 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
  9. 3 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
  10. 2 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
  11. 1 generation backK172819 LightWalker Laser System FamilyFotona D.O.O. · 2017
  12. This deviceK191554 LightWalker Laser System FamilyFotona D.O.O. · 2019

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2020: 22021: 22022: 32023: 22024: 32025: 42026: 3
2020high 4 (2025) · low 2 (2020)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−11K910422Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc.1992—
−10K961279Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc.1996—
−9K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc.1997—
−8K974536Photoderm HR SystemEsc Medical Systems, Ltd.1998—
−7K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.2000—
−6K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…Altus Medical, Inc.2002—
−5K023193Candela Gentle Yag Laser SystemCandela Corp.2002—
−4K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003—
−3K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag…Fotona D.D.2005—
−2K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008—
−1K172819LightWalker Laser System FamilyFotona D.O.O.2017—
0 (this device)K191554LightWalker Laser System FamilyFotona D.O.O.2019—
+1K193656SkyPulseFotona D.O.O.2020—
+1K193661LightWalker Laser System FamilyFotona D.O.O.2020—
+2K202985LightWalker Laser System FamilyFotona D.O.O.2021—
+2K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.2021—
+2K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198810
199010
199140
199350
199480
199560
199680
199790
199860
199940
2000100
2001100
2002140
200360
200440
200510
201510
201610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202120
202230
202320
202430
202540
202630
FIG. 1 — Lineage of K191554, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K172819LightWalker Laser System Family
Summary 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…
Fotona D.O.O.2017—
*K141861Hilthera 4.0
Summary 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…
Jeisys Medical, Inc.2015—

What descends from it? (19)

See all 19

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193656SkyPulseFotona D.O.O.202011
K193661LightWalker Laser System FamilyFotona D.O.O.20208

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 devices

GEX 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

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

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.

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

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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