510(k) · Cleared
ClearedLightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 2 generations backK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
- 1 generation backK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
- This deviceK121508 Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D. · 2012
- Descendant · cites it directly · 0 of its ownK182930 PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2019
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 6 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 5 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 4 generations backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- 3 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 2 generations backK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
- 1 generation backK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −6 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −5 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| −4 | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | Diomed, Inc. | 2004 | 1 |
| −3 | K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | Diomed, Ltd. | 2005 | — |
| −2 | K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP… | Fotona D.D. | 2009 | — |
| −1 | K101306 | SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models… | Fotona D.D. | 2011 | — |
| 0 (this device) | K121508 | Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N | Fotona D.D. | 2012 | — |
| +1 | K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | Millennium Dental Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 12 | 0 |
| 1995 | 10 | 0 |
| 1996 | 18 | 0 |
| 1997 | 18 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 14 | 0 |
| 2001 | 14 | 0 |
| 2002 | 18 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 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 K253960 Medicell Mycosis Laser (MCML24004)score 11.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101817 | Lightwalker 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… | 2010 |
| * | K093162 | Fidelis 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… | 2010 |
| * | K101306 | SP 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… | 2011 |
| * | K090126 | Fotona 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… | 2009 |
| * | K113702 | Fotona XP ND: Yag Laser SystemSummary 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… | 2012 |
| * | K103626 | Cutera Genesisplus Laser SystemSummary 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… | 2011 |
| * | K093547 | Pinpointe FootlaserSummary 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… | 2010 |
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 |
|---|---|---|---|
| K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | 2019 | 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 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 devicesPDZ 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
2026 to Oct 25, outlined.
Median 510(k) review, days · PDZ
196in 2012
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
MAUDE reports naming product code PDZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 205 | 0 | 0 |
| 2012 | 6 | 196 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 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.
https://510kreport.com/device/K121508 · printed Nov 5, 2026
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