510(k) Report

510(k) · Cleared

Cleared

Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N

K121508510(k) TraditionalCleared Dec 12, 2012205-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.D. · PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Cleared on Dec 12, 2012 as substantially equivalent to K101817 (Fotona D.D., 2010) and 6 other predicates after a 205-day review. Its family tree reaches back 12 generations to 1995. 1 later device descends from it.

Decided
Dec 12, 2012
Review
205 days
Class
Class II
Product code
PDZ
Recalls
None
Predicates
7

Its longest line of descent runs back 12 generations to K943450 (1995). 185 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 1 other ancestor2010: 4 other ancestors2009: 2 other ancestors2008: 4 other ancestors2006: 2 other ancestors2005: 2 other ancestors2004: 4 other ancestors2003: 7 other ancestors2002: 18 other ancestors2000: 14 other ancestors2001: 14 other ancestors1999: 6 other ancestors1998: 12 other ancestors1997: 18 other ancestors1996: 18 other ancestors1995: 10 other ancestors1994: 12 other ancestors1993: 6 other ancestors1992: 3 other ancestors1991: 7 other ancestors1990: 2 other ancestors1989: 1 other ancestor1988: 1 other ancestor1982: 1 other ancestor1985: 1 other ancestor1980: 1 other ancestor1986: 1 other ancestor2019: 1 descendant clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) ×2: 2 generations cleared close together, K964849 (1997), K971532 (1997) K974521 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1998K982816 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1999K012398 · Diomed 15 Diode Laser · Diomed, Ltd. · 2002K041957 · Evlt Kit and the D15PLUS and D30PLUS Diode Lasers · Diomed, Inc. · 2004 · recalledK051996 · Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 · Diomed, Ltd. · 2005K090126 · Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2, · Fotona D.D. · 2009K101306 · SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A · Fotona D.D. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 20 other ancestors3 generations back: 32 other ancestors4 generations back: 39 other ancestors5 generations back: 37 other ancestors6 generations back: 19 other ancestors7 generations back: 19 other ancestors8 generations back: 2 other ancestors 1 generation forward: 1 descendant K101306 · SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A · Fotona D.D. · 2011K090126 · Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2, · Fotona D.D. · 2009K051996 · Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 · Diomed, Ltd. · 2005K041957 · Evlt Kit and the D15PLUS and D30PLUS Diode Lasers · Diomed, Inc. · 2004 · recalledK012398 · Diomed 15 Diode Laser · Diomed, Ltd. · 2002K982816 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1999K974521 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1998K971532 · Arthrocare Electrosurgery System · Arthrocare Corp. · 1997K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−10−50
  1. Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 8 generations between
  3. 3 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
  4. 2 generations backK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
  5. 1 generation backK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
  6. This deviceK121508 Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D. · 2012
  7. Descendant · cites it directly · 0 of its ownK182930 PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2019
Show all 12 generations
  1. Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 8 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  6. 7 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
  7. 6 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
  8. 5 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
  9. 4 generations backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
  10. 3 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
  11. 2 generations backK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
  12. 1 generation backK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
  13. This deviceK121508 Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D. · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−11K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−10K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−9K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−8K971532Arthrocare Electrosurgery SystemArthrocare Corp.1997—
−7K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998—
−6K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999—
−5K012398Diomed 15 Diode LaserDiomed, Ltd.2002—
−4K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc.20041
−3K051996Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd.2005—
−2K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP…Fotona D.D.2009—
−1K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.2011—
0 (this device)K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.2012—
+1K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198210
198510
198610
198810
198910
199020
199170
199230
199360
1994120
1995100
1996180
1997180
1998120
199960
2000140
2001140
2002180
200370
200440
200520
200620
200840
200920
201040
201110
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K121508, 1995–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 PDZ? 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 PDZ device

  1. #1 K253960 Medicell Mycosis Laser (MCML24004)score 11.3 · 2 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? (7)

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
*K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…
Summary page 4
…tona |Fotona Fotona Dynamis Fotona XP . Fotona Fidelis Il |LightWalkerLaser Laser System Nd:YAG Laser | LightWalker {(K093162) [System Family Family System Family Laser (K101817) (K101306) (K090126) System (K113702) Family {(new submission) Wavelength| 1064 nm 1064 nm 1064 nm 1064 nm 1064 nm Flashlamp Flas…
Fotona D.D.2010—
*K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…
Summary page 4
…3: Comparison table for Nd: YAG laser wavelength Fotona |Fotona Fotona Dynamis Fotona XP . Fotona Fidelis Il |LightWalkerLaser Laser System Nd:YAG Laser | LightWalker {(K093162) [System Family Family System Family Laser (K101817) (K101306) (K090126) System (K113702) Family {(new submission) Wavelength| 10…
Fotona D.D.2010—
*K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…
Summary page 4
…na Fotona Dynamis Fotona XP . Fotona Fidelis Il |LightWalkerLaser Laser System Nd:YAG Laser | LightWalker {(K093162) [System Family Family System Family Laser (K101817) (K101306) (K090126) System (K113702) Family {(new submission) Wavelength| 1064 nm 1064 nm 1064 nm 1064 nm 1064 nm Flashlamp Flash lam Flas…
Fotona D.D.2011—
*K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…
Summary page 4
…Dynamis Fotona XP . Fotona Fidelis Il |LightWalkerLaser Laser System Nd:YAG Laser | LightWalker {(K093162) [System Family Family System Family Laser (K101817) (K101306) (K090126) System (K113702) Family {(new submission) Wavelength| 1064 nm 1064 nm 1064 nm 1064 nm 1064 nm Flashlamp Flash lam Flashlamp Lase…
Fotona D.D.2009—
*K113702Fotona XP ND: Yag Laser System
Summary page 4
…. Fotona Fidelis Il |LightWalkerLaser Laser System Nd:YAG Laser | LightWalker {(K093162) [System Family Family System Family Laser (K101817) (K101306) (K090126) System (K113702) Family {(new submission) Wavelength| 1064 nm 1064 nm 1064 nm 1064 nm 1064 nm Flashlamp Flash lam Flashlamp Laser pumped | Flashl…
Fotona D.D.2012—
*K103626Cutera Genesisplus Laser System
Summary page 5
…ily (K093162), Fotona Dynamis Er:YAG/Nd:YAG Laser System Family (K101306), Fotona XP Nd:YAG Laser System Family (K090126) and (K113702), Cutera GenesisPlus Laser System (K103626) and PinPointe FootLaser (K093547). The Fotona LightWalker Er:YAG/Nd:YAG Laser System Family is substantially equivalent in terms…
Cutera, Inc.2011—
*K093547Pinpointe Footlaser
Summary page 5
…AG/Nd:YAG Laser System Family (K101306), Fotona XP Nd:YAG Laser System Family (K090126) and (K113702), Cutera GenesisPlus Laser System (K103626) and PinPointe FootLaser (K093547). The Fotona LightWalker Er:YAG/Nd:YAG Laser System Family is substantially equivalent in terms of indications for use and techno…
Pinpointe USA, Inc.2010—

Also cleared against K101817: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190

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 17 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 7 of the 185 ancestors have a recall of any class.
  • Of its descendants, K182930 (Millennium Dental Technologies, Inc., 2019) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K101817.

How does its category compare?

All PDZ devices

PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · PDZ

1in 2024

2010: 12011: 42012: 62013: 12015: 12016: 12019: 12022: 22024: 12026 (partial year): 1
2007high 6 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PDZ

196in 2012

2011: 205 days median2012: 196 days median
2007high 205 (2011) · low 196 (2012)2026

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

Recalls per year · PDZ

No recall names PDZ since 2007.

Adverse event reports per year · PDZ

1in 2019

2018: 22019: 1
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code PDZ, 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
20070—00
20080—00
20090—00
20101—00
2011420500
2012619600
20131—00
20140—00
20151—00
20161—00
20170—00
20180—02
20191—01
20200—00
20210—00
20222—00
20230—00
20241—00
20250—00
20261—0—

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 cleamng, root canal preparation including enlargement…

Read the full statement (543 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 cleamng, root canal preparation including enlargement

Cutting, shaving, contouring and resection of oral osseous tissue (bone)

Osleotomy, osseous crown lengthening, osleoplasty

Apicectomy surgery

Removal of subgingival calculi in pcnodomal 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, hyperkerat051s 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 intcrnal organs, lesions, tissue ablation and vessel coagulation;

Podiatry Indications: Warts, plantar verrucac, large mosaic verrucae, matrixectomy;

Ophthalmology Indications: Soft tissue surrounding the eye;

Gynecology Indications; Herpes simplex, endometrial adhesion, CIN (Cerv:cal mtraepnhehal neoplasia), cysts, condiloma;

Nd:YAG laser (1064 nm wavelength) in dentistry:

Excisional and incisional biopsies

Excision and vaporization of herpes simplex Iand 11

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

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. 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.

Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasia, 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 sofl 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: Matrixcctomy

Periungual and subungual warts

Plantar warts

Radical nail cxcision

Neuromas

The Fotc;na LightWalker Laser System Family is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophyies, and/or yeasts Candida albicans, eic.).

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. “K121508: Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121508

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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