510(k) · Cleared
ClearedFotona Fidelis Plus ND:Yag Laser System
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 Jul 7, 2003 after a 199-day review. The FDA summary names its predicate without a number. 200 later devices descend from it.
- Decided
- Jul 7, 2003
- Review
- 199 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
200 later devices descend from it, 2 citing it directly.
- This deviceK024204 Fotona Fidelis Plus ND:Yag Laser SystemFotona D.D. · 2003
- Descendant · cites it directly · 194 of its ownK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- Descendant · 2 generations on · 166 of its ownK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- Descendant · 3 generations on · 92 of its ownK103455 Spectra Laser SystemLutronic Corporation · 2011
- Descendant · cites it directly · 83 of its ownK093162 Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii…Fotona D.D. · 2010
- Descendant · 4 generations on · 82 of its ownK113588 Spectra Laser SystemLutronic Corporation · 2012
Showing 5 of 200 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 200 · See all- K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008 · cites it directly194descendants
- K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009 · 2 generations on166descendants
- K103455Spectra Laser SystemLutronic Corporation · 2011 · 3 generations on92descendants
- K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D. · 2010 · cites it directly83descendants
- K113588Spectra Laser SystemLutronic Corporation · 2012 · 4 generations on82descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024204 | Fotona Fidelis Plus ND:Yag Laser System | Fotona D.D. | 2003 | — |
| +1 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| +2 | K083889 | Fotona QX ND:Yag/KTP Laser System Family | Fotona D.D. | 2009 | — |
| +3 | K103455 | Spectra Laser System | Lutronic Corporation | 2011 | — |
| +1 | K093162 | Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at… | Fotona D.D. | 2010 | — |
| +4 | K113588 | Spectra Laser System | Lutronic Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 12 | 0 |
| 2017 | 14 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 10 | 0 |
| 2021 | 14 | 0 |
| 2022 | 24 | 0 |
| 2023 | 13 | 0 |
| 2024 | 21 | 0 |
| 2025 | 26 | 0 |
| 2026 | 19 | 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 |
|---|---|---|---|
| * | — | Sunlase 8001 Nd:YAG laser system Named without a submission number |
What descends from it? (200)
See all 2002 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?
- Of its descendants, K070355 (Fotona D.D., 2008) has gone furthest, with 194 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.
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?
The Fotona Fidelis Plus Nd:YAG Laser System and Accessories is intended for inusion. excision and coagulation of intraoral soft tissue, including the marginal and interdental gingiva. This includes incising, excising and coagulating the epithelium lining. the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket). Excisionat and incisional biopsies Excision and vaporization of herpex simplex…
Read the full statement (187 words)
The Fotona Fidelis Plus Nd:YAG Laser System and Accessories is intended for inusion. excision and coagulation of intraoral soft tissue, including the marginal and interdental gingiva. This includes incising, excising and coagulating the epithelium lining. the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
Excisionat and incisional biopsies
Excision and vaporization of herpex simplex I and I1
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)
Leukoplakia
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
Sulculardebridement 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 apthous ulcers
Vestibuloptasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024204: Fotona Fidelis Plus ND:Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024204
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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