510(k) · Cleared
ClearedLightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E, Model M002-6A/2, Lightwalker ST-N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fotona D.D. · GEX Powered Laser Surgical Instrument
Cleared on Nov 22, 2010 as substantially equivalent to K093162 (Fotona D.D., 2010) after a 145-day review. Its family tree reaches back 10 generations to 1992. 5 later devices descend from it.
- Decided
- Nov 22, 2010
- Review
- 145 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K910422 (1992). 107 ancestors in all, the oldest K820106 (1982). 5 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 1 generation backK093162 Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii…Fotona D.D. · 2010
- This deviceK101817 Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2…Fotona D.D. · 2010
- Descendant · cites it directly · 2 of its ownK130420 SOLEAConvergent Dental, Inc. · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK151306 SoleaConvergent Dental, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK121508 Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D. · 2012
- Descendant · 2 generations on · 0 of its ownK221761 SoleaConvergent Dental, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK182930 PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2019
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 1 generation backK093162 Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii…Fotona D.D. · 2010
- This deviceK101817 Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2…Fotona D.D. · 2010
Most influential descendants
Showing 5 of 5 · See all- K130420SOLEAConvergent Dental, Inc. · 2013 · cites it directly2descendants
- K151306SoleaConvergent Dental, Inc. · 2015 · cites it directly1descendant
- K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D. · 2012 · cites it directly1descendant
- K221761SoleaConvergent Dental, Inc. · 2022 · 2 generations on0descendants
- K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −2 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −1 | K093162 | Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at… | Fotona D.D. | 2010 | — |
| 0 (this device) | K101817 | Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2… | Fotona D.D. | 2010 | — |
| +1 | K130420 | SOLEA | Convergent Dental, Inc. | 2013 | 1 |
| +1 | K151306 | Solea | Convergent Dental, Inc. | 2015 | — |
| +1 | K121508 | Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N | Fotona D.D. | 2012 | — |
| +2 | K221761 | Solea | Convergent Dental, Inc. | 2022 | 1 |
| +2 | 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 |
|---|---|---|
| 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 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K093162 | Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Summary page 3…h, and therefore Fotona d.d. believes that its LightWalker laser system family is substantially equivalent to, the Fotona Fidelis III Er-•YAGINd:YAG Laser System Family (K093 162) previously cleared for incision, excision, vaporization, ablation and coagulation of soft and hard tissue in the mouth. Details… | 2010 |
What descends from it? (5)
3 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 18 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 107 ancestors have a recall of any class.
- Of its descendants, K130420 (Convergent Dental, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K093162.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 (447 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 nmn wavelength) in dermatology and o ther surgical areas:
- Dermatology and Plastic SueryM 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 Surger 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;
- Podiatr Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;
Nd:YAG laser (1064 tim 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 trou-ghing 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 imflamned 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 inn 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, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101817: Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E, Model M002-6A/2, Lightwalker ST-N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101817
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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