510(k) Report

510(k) · Cleared

Cleared

Fotona Dualis ND:Yag/ER:Yag Laser System

K021548510(k) TraditionalCleared Dec 6, 2002207-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Descendants, by year cleared 2008: 1 descendant cleared2010: 6 descendants cleared2011: 6 descendants cleared2013: 6 descendants cleared2009: 4 descendants cleared2017: 20 descendants cleared2018: 16 descendants cleared2012: 12 descendants cleared2015: 13 descendants cleared2014: 9 descendants cleared2020: 12 descendants cleared2022: 27 descendants cleared2021: 15 descendants cleared2016: 14 descendants cleared2019: 9 descendants cleared2026: 19 descendants cleared2023: 15 descendants cleared2025: 28 descendants cleared2024: 21 descendants cleared200020052010201520202025
  1. This deviceK021548 Fotona Dualis ND:Yag/ER:Yag Laser SystemFotona D.D. · 2002
  2. Descendant · cites it directly · 194 of its ownK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
  3. Descendant · 2 generations on · 166 of its ownK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
  4. Descendant · 3 generations on · 92 of its ownK103455 Spectra Laser SystemLutronic Corporation · 2011
  5. 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
  6. 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

2008: 12009: 42010: 62011: 62012: 122013: 62014: 92015: 132016: 142017: 202018: 162019: 92020: 122021: 152022: 272023: 152024: 212025: 282026: 19
2008high 28 (2025) · low 1 (2008)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021548Fotona Dualis ND:Yag/ER:Yag Laser SystemFotona D.D.2002—
+1K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009—
+3K103455Spectra Laser SystemLutronic Corporation2011—
+1K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at…Fotona D.D.2010—
+4K113588Spectra Laser SystemLutronic Corporation2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200940
201060
201160
2012120
201360
201490
2015130
2016140
2017200
2018160
201990
2020120
2021150
2022270
2023150
2024210
2025280
2026190
FIG. 1 — Lineage of K021548, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—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 253

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194
K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083
K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178
K082947Lensx 550 Laser SystemLensx Lasers, Inc.200951
K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130

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 devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

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.

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