510(k) · Cleared
ClearedFotona Dualis ND:Yag/ER: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 Dec 6, 2002 after a 207-day review. The FDA summary names its predicate without a number. 253 later devices descend from it.
- Decided
- Dec 6, 2002
- Review
- 207 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
253 later devices descend from it, 5 citing it directly.
- This deviceK021548 Fotona Dualis ND:Yag/ER:Yag Laser SystemFotona D.D. · 2002
- 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 253 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 253 · 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) | K021548 | Fotona Dualis ND:Yag/ER:Yag Laser System | Fotona D.D. | 2002 | — |
| +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 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 12 | 0 |
| 2013 | 6 | 0 |
| 2014 | 9 | 0 |
| 2015 | 13 | 0 |
| 2016 | 14 | 0 |
| 2017 | 20 | 0 |
| 2018 | 16 | 0 |
| 2019 | 9 | 0 |
| 2020 | 12 | 0 |
| 2021 | 15 | 0 |
| 2022 | 27 | 0 |
| 2023 | 15 | 0 |
| 2024 | 21 | 0 |
| 2025 | 28 | 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? (2)
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 |
|---|---|---|---|
| * | — | Fotona Dualis long pulse Nd:YAG laser system Named without a submission number | |
| * | — | Fotona Fidelis Er:YAG laser system Named without a submission number |
What descends from it? (253)
See all 2535 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | 2008 | 194 |
| K093162 | Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis… | 2010 | 83 |
| K101306 | SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models… | 2011 | 78 |
| K082947 | Lensx 550 Laser System | 2009 | 51 |
| K122368 | Waterlase Iplus All Tissue Laser | 2013 | 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?
- 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?
Nd:YAG Laser (1064 nm) The Fotona DualisSP Nd:YAG laser is intended for incision, ablation, vaporization, and coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent redudion of unwanted hair in Fitzpatrick skih types I VI. Dermatology: Coagulation and hemostasis of vascular lesions, and To effect stable long-term, or permanent, hair reduction in skin types I - VI through selective targeting of melanin…
Read the full statement (409 words)
Nd:YAG Laser (1064 nm)
The Fotona DualisSP Nd:YAG laser is intended for incision, ablation, vaporization, and coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent redudion of unwanted hair in Fitzpatrick skih types I VI.
Dermatology: Coagulation and hemostasis of vascular lesions, and To effect stable long-term, or permanent, hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Plastic Sumem: Coagulation and vaporization of soft tissue.
Otorinolarynqoloqv /Head and Neck (ENT): Tissue ablation and vessel hemostasis.
Hemostasis durinq Sumery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.
Orthopedics: Ablation, vaporization, incision, excision, coagulation, and hernostasis of soft and cartilaginous tissue in small and large joints including but not limited to knee menisectomy, knee synovedomy, chondromaliacia and tears, shoulder debridement of scar tissue, and synovectomy of the shoulder.
Neurosurqery: hemostasis in neurosurgery procedures such as excision of brain lesions, spinal cord lesions cranial nerves, peripheral nerves, and pituitary glands.
Gastroenteroloqv: Tissue ablation and hemostasis in the gastrointestinal trad, cshophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; Gastrintestinal hemostatsis including varices, espohagitis, esopageat ulcer, Mallory-Weiss tear, gastric ulcer, stomac ulcers, angiodysplasia, non-bleeding ulcers, gastric erosions; Gastrintestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorroids.
Er:YAG Laser (2940 nm)
The Fotona Dualis'' Er:YAG laser is intended for surgical incision/excision, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, cartilage meniscus, muscle, mucous membrane, lymph vessels arid nodes, organs and glands.
Dermatoloqy an Plastic Surqery Indications: Epidermal nevi, telangiectasias, spider veins, actinic sheilitis. keloids, verrucae, skin tags, anal tags, keratoses, scar revision, decubitis ulcers, and skin resurfacing.
ENT Surqery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia
Gynecoloqy Indications: Herpes simplex. endornaterial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, and condiloma.
General Surqery 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.
Oral/Maxillofacial Indications: Oral and'glossai lesions and gingivectomy
Ophtalmoloqv Indications: Soft tissue surrounding the eye and orbit and anterior capsulotomy
Pod.iatw Indications: Warts, plantar verrucae, large mosaic verrucae and matrixectomy
Dentistw indications: Canes removal, cavity preparation, enamel etching
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021548 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021548: Fotona Dualis ND:Yag/ER:Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021548
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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