510(k) Report

510(k) · Cleared

Cleared

XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro

K182088510(k) TraditionalCleared Oct 31, 201890-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.O.O. · GEX Powered Laser Surgical Instrument

Cleared on Oct 31, 2018 as substantially equivalent to K143723 (Fotona D.D., 2015) after a 90-day review. Its family tree reaches back 21 generations to 1995. 20 later devices descend from it.

Decided
Oct 31, 2018
Review
90 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
1

Its longest line of descent runs back 21 generations to K943450 (1995). 540 ancestors in all, the oldest K771218 (1978). 20 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 2 other ancestors2010: 5 other ancestors2009: 10 other ancestors2005: 28 other ancestors1999: 28 other ancestors2008: 19 other ancestors2007: 17 other ancestors2006: 17 other ancestors2004: 34 other ancestors2003: 47 other ancestors2002: 42 other ancestors2000: 36 other ancestors1998: 33 other ancestors1997: 31 other ancestors2001: 34 other ancestors1996: 30 other ancestors1995: 26 other ancestors1994: 27 other ancestors1993: 12 other ancestors1991: 9 other ancestors1990: 7 other ancestors1992: 6 other ancestors1988: 4 other ancestors1982: 2 other ancestors1989: 5 other ancestors1986: 1 other ancestor1985: 1 other ancestor1981: 1 other ancestor1980: 1 other ancestor1978: 1 other ancestor1987: 2 other ancestors2020: 2 descendants cleared2021: 2 descendants cleared2022: 4 descendants cleared2023: 2 descendants cleared2025: 4 descendants cleared2024: 3 descendants cleared2026: 3 descendants clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006×2: 2 generations cleared close together, K071295 (2007), K072106 (2007) K083682 · 180W Cerelas D 980NM Diode Laser, Model D180 · Biolitec, Inc. · 2009K082230 · Vectra Plus Laser System and Accessories · Xintec Corporation · 2010K101916 · Joule Multi-Platform System · Sciton, Inc · 2011K132806 · Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece · Fotona D.D. · 2014K143723 · SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro · Fotona D.D. · 201519801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 7 other ancestors3 generations back: 27 other ancestors4 generations back: 72 other ancestors5 generations back: 131 other ancestors6 generations back: 145 other ancestors7 generations back: 95 other ancestors8 generations back: 36 other ancestors9 generations back: 6 other ancestors 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 6 descendants K143723 · SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro · Fotona D.D. · 2015K132806 · Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece · Fotona D.D. · 2014K101916 · Joule Multi-Platform System · Sciton, Inc · 2011K082230 · Vectra Plus Laser System and Accessories · Xintec Corporation · 2010K083682 · 180W Cerelas D 980NM Diode Laser, Model D180 · Biolitec, Inc. · 2009K072106 · 150W Ceralas D 980NM Diode Laser · Biolitec, Inc. · 2007K071295 · 100W Ceralas D 980NM Diode Laser · Biolitec, Inc. · 2007K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−20−15−10−50
  1. Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 17 generations between
  3. 3 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
  4. 2 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
  5. 1 generation backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
  6. This deviceK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
  7. Descendant · cites it directly · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
  8. Descendant · cites it directly · 8 of its ownK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
  9. Descendant · cites it directly · 7 of its ownK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
  10. Descendant · 2 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
  11. Descendant · 2 generations on · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
Show all 21 generations
  1. Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 9 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  14. 8 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  15. 7 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  16. 6 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  17. 5 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
  18. 4 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
  19. 3 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
  20. 2 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
  21. 1 generation backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
  22. This deviceK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2020: 22021: 22022: 42023: 22024: 32025: 42026: 3
2020high 4 (2022) · low 2 (2020)2026

Most influential descendants

Showing 5 of 20 · See all
  • K193656SkyPulseFotona D.O.O. · 2020 · cites it directly11descendants
  • K193661LightWalker Laser System FamilyFotona D.O.O. · 2020 · cites it directly8descendants
  • K202985LightWalker Laser System FamilyFotona D.O.O. · 2021 · cites it directly7descendants
  • K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 2 generations on3descendants
  • K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−20K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−19K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−18K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−17K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−16K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−15K000944Thermage Thermacool SystemThermage, Inc.2000—
−14K013034Modification to: Thermacool IiaThermage, Inc.2001—
−13K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−12K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−11K030142Thermacool TC SystemThermage, Inc.2003—
−10K031671Polaris WRSyneron Medical, Ltd.2003—
−9K041959Polaris DS/CometSyneron Medical, Ltd.2004—
−8K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
−7K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−6K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−5K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009—
−4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010—
−3K101916Joule Multi-Platform SystemSciton, Inc2011—
−2K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.2014—
−1K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.2015—
0 (this device)K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.2018—
+1K193656SkyPulseFotona D.O.O.2020—
+1K193661LightWalker Laser System FamilyFotona D.O.O.2020—
+1K202985LightWalker Laser System FamilyFotona D.O.O.2021—
+2K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.2021—
+2K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198010
198110
198220
198510
198610
198720
198840
198950
199070
199190
199260
1993120
1994270
1995260
1996300
1997310
1998330
1999280
2000360
2001340
2002420
2003470
2004340
2005280
2006170
2007170
2008190
2009100
201050
201120
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202120
202240
202320
202430
202540
202630
FIG. 1 — Lineage of K182088, 1995–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
Summary page 5
…al and Plastic Surgery 21 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICE • Fotona Dynamis Pro Family (K143723) DEVICE DESCRIPTION The Dynamis Pro Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The laser unit a…
Fotona D.D.2015—

Also cleared against K143723: 3 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K193656SkyPulseFotona D.O.O.202011
K193661LightWalker Laser System FamilyFotona D.O.O.20208
K202985LightWalker Laser System FamilyFotona D.O.O.20217
K213267Dynamis Pro FamilyFotona D.O.O.20222
K213350mJOULE System and AccessoriesSciton, Inc20220

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 23 years and passes through 9 companies; a new generation was cleared every 10 months on median.
  • 26 of the 540 ancestors have a recall of any class.
  • Of its descendants, K193656 (Fotona D.O.O., 2020) has gone furthest, with 11 descendants of its own.
  • 3 other devices also cite its predicate K143723.

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. 2018, this device’s year, is highlighted.

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?

Er:YAG laser (2940 nm wavelength): The Dynamis Er:YAG laser is intended for surgical incision/excision, cutting ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. - Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis…

Read the full statement (567 words)

Er:YAG laser (2940 nm wavelength):

The Dynamis Er:YAG laser is intended for surgical incision/excision, cutting ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.

- Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing;

- Soft tissue resurfacing with S22 and S22-T scanner;

- ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;

- Oral/Maxillofacial Indications: Oral and glossal lesions;

- Ophtalmology Indications: Soft tissue surrounding the eye ;

- Intra-oral soft tissue incision, excision, ablation, coagulation;

- 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 is necessary;

- Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;

- Genitourinary Indications:lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon;

- Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;

- The Fotona F-22 Handpiece is intended for:

• In fractionated mode:

- Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;

• In non-fractionated mode:

- 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 is necessary;

- The Fotona FS-01 Handpiece is intended for:

- Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;

Nd:YAG laser (1064 nm wavelength):

The Dynamis Nd:YAG laser is intended for incision, ablation,vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.

- Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy;

- Treatment of Aphthous Ulcers;

- Excision and Vaporization of Herpex Simplex I and II;

- Laser assisted uvulopaletoplasty (LAUP);

- Laser assisted lipolysis;

- 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. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regime;

- Treatment of wrinkles;

- Treatment of wrinkles with S11 scanner;

- Treatment of mild to moderate inflammatory acne vulgaris;

- 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;

- Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

- Matrixectomy

- Radical nail excision

- Periungual and subungual warts

- Plantar warts

- Neuromas

- Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

- Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K182088: XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182088

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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