510(k) · Cleared
ClearedFotona Fidelis Iii ER:Yag/ND:Yag Laser System Family
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 Mar 4, 2008 as substantially equivalent to K001527 (Fotona D.D., 2000) and 7 other predicates after a 392-day review. Its family tree reaches back 9 generations to 1992. 194 later devices descend from it.
- Decided
- Mar 4, 2008
- Review
- 392 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 9 generations to K910422 (1992). 106 ancestors in all, the oldest K820106 (1982). 194 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- This deviceK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- Descendant · cites it directly · 166 of its ownK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- Descendant · 2 generations on · 92 of its ownK103455 Spectra Laser SystemLutronic Corporation · 2011
- Descendant · 3 generations on · 82 of its ownK113588 Spectra Laser SystemLutronic Corporation · 2012
- Descendant · cites it directly · 80 of its ownK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
- Descendant · 2 generations on · 78 of its ownK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- This deviceK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
Showing 5 of 194 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 194 · See all- K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009 · cites it directly166descendants
- K103455Spectra Laser SystemLutronic Corporation · 2011 · 2 generations on92descendants
- K113588Spectra Laser SystemLutronic Corporation · 2012 · 3 generations on82descendants
- K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D. · 2009 · cites it directly80descendants
- K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D. · 2011 · 2 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −3 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −2 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −1 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| 0 (this device) | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| +1 | K083889 | Fotona QX ND:Yag/KTP Laser System Family | Fotona D.D. | 2009 | — |
| +2 | K103455 | Spectra Laser System | Lutronic Corporation | 2011 | — |
| +3 | K113588 | Spectra Laser System | Lutronic Corporation | 2012 | — |
| +1 | K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP… | Fotona D.D. | 2009 | — |
| +2 | K101306 | SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models… | Fotona D.D. | 2011 | — |
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 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 12 | 0 |
| 2017 | 14 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 10 | 0 |
| 2021 | 14 | 0 |
| 2022 | 23 | 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? (8)
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 |
|---|---|---|---|
| * | K001527 | Fotona Fidelis ER: Yag Laser System and AccesoriesSummary page 7…al features with, and therefore Fotona d.d. believes that its Fidelis III laser system family is substantially equivalent to, the a) Fotona Fidelis Er:YAG Laser System (K001527) previously cleared for incision, excision, vaporization, ablation and coagulation of soft and hard tissue in the mouth; b) Foto… | 2000 |
| * | K024204 | Fotona Fidelis Plus ND:Yag Laser SystemSummary page 7…527) previously cleared for incision, excision, vaporization, ablation and coagulation of soft and hard tissue in the mouth; b) Fotona Fidelis Plus Nd:YAG Laser System (K024204) previously cleared as an accessory for Fotona Fidelis Er:YAG Laser System (K001527) for incision, excision and coagulation of in… | 2003 |
| * | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Summary page 7…ser System (K001527) for incision, excision and coagulation of intra oral soft tissue, including the marginal and inter dental gingiva; ¢) Fotona XP Plus Nd:YAG Family (K050293) previously cleared for surgical and aesthetic applications in soft tissue in the medical specialities of general and plastic sur… | 2005 |
| * | K021548 | Fotona Dualis ND:Yag/ER:Yag Laser SystemSummary page 7…rgical and aesthetic applications in soft tissue in the medical specialities of general and plastic surgery and dermatology; d) Fotona Duatis Nd:YAG/Er:YAG Laser System (K021548) previously cleared for surgical incision/excision, vaporization and coagulation of soft and hard tissue; e) Hoya ConBio -VersaW… | 2002 |
| * | K041710 | Versawave Dental ER:Yag Laser SystemSummary page 7…(K021548) previously cleared for surgical incision/excision, vaporization and coagulation of soft and hard tissue; e) Hoya ConBio -VersaWave Dental Er:YAG Laser System (K041710) previously cleared for various hard tissue and soft tissue dental indications; f) Millennium Periolase Nd:YAG Laser System (K03… | 2004 |
| * | K030290 | Periolase ND:Yag Dental Laser SystemSummary page 7…rsaWave Dental Er:YAG Laser System (K041710) previously cleared for various hard tissue and soft tissue dental indications; f) Millennium Periolase Nd:YAG Laser System (K030290) previously cleared for various dental indications; g) Cooltouch Nd:YAG Laser System previously cleared for the treatment of mil… | 2004 |
| * | K040131 | Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemSummary page 7…previously cleared for various dental indications; g) Cooltouch Nd:YAG Laser System previously cleared for the treatment of mild to moderate inflammatory acne vulgaris (K040131). h) Laserscope Gemini Laser System previously cleared for the treatment of mild to moderate inflammatory acne vulgaris (K034011… | 2004 |
| * | K034011 | Gemini Surgical Laser System & AccessoriesSummary page 7…to moderate inflammatory acne vulgaris (K040131). h) Laserscope Gemini Laser System previously cleared for the treatment of mild to moderate inflammatory acne vulgaris (K034011) Details are provided in the Substantial Equivalence Discussion Section of this submission. 510(k) Submission: Fotona Fidelis I… | 2004 |
What descends from it? (194)
See all 1944 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 16 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 106 ancestors have a recall of any class.
- Of its descendants, K083889 (Fotona D.D., 2009) has gone furthest, with 166 descendants of its own.
- 3 other devices also cite its predicate K001527.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 including enlargement…
Read the full statement (406 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
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;
Nd:YAG laser (1064 nm 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 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 imflamed 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)
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, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070355 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070355: Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070355
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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