510(k) Report

510(k) · Cleared

Cleared

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

K143723510(k) TraditionalCleared Apr 9, 2015101-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 Apr 9, 2015 as substantially equivalent to K101306 (Fotona D.D., 2011) and 7 other predicates after a 101-day review. Its family tree reaches back 20 generations to 1995. 62 later devices descend from it.

Decided
Apr 9, 2015
Review
101 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
8

Its longest line of descent runs back 20 generations to K943450 (1995). 539 ancestors in all, the oldest K771218 (1978). 62 later devices descend from it, 4 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 ancestors2017: 2 descendants cleared2016: 1 descendant cleared2018: 4 descendants cleared2021: 4 descendants cleared2019: 2 descendants cleared2023: 7 descendants cleared2020: 5 descendants cleared2022: 8 descendants cleared2025: 11 descendants cleared2024: 9 descendants cleared2026: 9 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. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 27 other ancestors3 generations back: 72 other ancestors4 generations back: 131 other ancestors5 generations back: 145 other ancestors6 generations back: 95 other ancestors7 generations back: 36 other ancestors8 generations back: 6 other ancestors 1 generation forward: 4 descendants2 generations forward: 13 descendants3 generations forward: 16 descendants4 generations forward: 14 descendants5 generations forward: 9 descendants6 generations forward: 5 descendants7 generations forward: 1 descendant K132806 · 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+5
  1. Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 16 generations between
  3. 3 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
  4. 2 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
  5. 1 generation backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
  6. This deviceK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
  7. Descendant · cites it directly · 32 of its ownK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
  8. Descendant · 2 generations on · 24 of its ownK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
  9. Descendant · 3 generations on · 22 of its ownK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
  10. Descendant · cites it directly · 20 of its ownK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
  11. Descendant · 4 generations on · 14 of its ownK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
Show all 20 generations
  1. Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 9 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 8 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  14. 7 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  15. 6 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  16. 5 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  17. 4 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
  18. 3 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
  19. 2 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
  20. 1 generation backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
  21. This deviceK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

2016: 12017: 22018: 42019: 22020: 52021: 42022: 82023: 72024: 92025: 112026: 9
2016high 11 (2025) · low 1 (2016)2026

Most influential descendants

Showing 5 of 62 · See all
  • K153671Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016 · cites it directly32descendants
  • K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc. · 2017 · 2 generations on24descendants
  • K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc. · 2018 · 3 generations on22descendants
  • K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018 · cites it directly20descendants
  • K222064The Alma Soprano TitaniumAlma Lasers, Inc. · 2022 · 4 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−19K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−18K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−17K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−16K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−15K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−14K000944Thermage Thermacool SystemThermage, Inc.2000—
−13K013034Modification to: Thermacool IiaThermage, Inc.2001—
−12K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−11K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−10K030142Thermacool TC SystemThermage, Inc.2003—
−9K031671Polaris WRSyneron Medical, Ltd.2003—
−8K041959Polaris DS/CometSyneron Medical, Ltd.2004—
−7K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
−6K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−5K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−4K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009—
−3K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010—
−2K101916Joule Multi-Platform SystemSciton, Inc2011—
−1K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.2014—
0 (this device)K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.2015—
+1K153671Family of CoolGlide Aesthetic LasersCutera, Inc.2016—
+2K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology…Alma Lasers, Inc.2017—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology…Alma Lasers, Inc.2018—
+1K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.2018—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.2022—

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
201610
201720
201840
201920
202050
202140
202280
202370
202490
2025110
202690
FIG. 1 — Lineage of K143723, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…
Summary page 5
…on Name: Powered laser surgical instrument with microbeam\fractional output Product Code: ONG, GEX 3. PREDICATE DEVICES - Fotona Dynamis Laser System Family (K101306) - Fotona F-22 Laser Handpiece, Fotona FS-01 Laser Handpiece (K132806) - Fotona XP Nd:YAG Laser System Family (K113702) - Fotona…
Fotona D.D.2011—
*K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece
Summary page 5
…utput Product Code: ONG, GEX 3. PREDICATE DEVICES - Fotona Dynamis Laser System Family (K101306) - Fotona F-22 Laser Handpiece, Fotona FS-01 Laser Handpiece (K132806) - Fotona XP Nd:YAG Laser System Family (K113702) - Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family (K093162) - Fotona XP Nd…
Fotona D.D.2014—
*K113702Fotona XP ND: Yag Laser System
Summary page 5
…ATE DEVICES - Fotona Dynamis Laser System Family (K101306) - Fotona F-22 Laser Handpiece, Fotona FS-01 Laser Handpiece (K132806) - Fotona XP Nd:YAG Laser System Family (K113702) - Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family (K093162) - Fotona XP Nd:YAG Laser System Family (K090126) - Fotona QX Nd…
Fotona D.D.2012—
*K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…
Summary page 5
…ona F-22 Laser Handpiece, Fotona FS-01 Laser Handpiece (K132806) - Fotona XP Nd:YAG Laser System Family (K113702) - Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family (K093162) - Fotona XP Nd:YAG Laser System Family (K090126) - Fotona QX Nd:YAG/KTP Laser System Family (K083889) - Fotona XP Plus Nd:YAG Fa…
Fotona D.D.2010—
*K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…
Summary page 5
…piece (K132806) - Fotona XP Nd:YAG Laser System Family (K113702) - Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family (K093162) - Fotona XP Nd:YAG Laser System Family (K090126) - Fotona QX Nd:YAG/KTP Laser System Family (K083889) - Fotona XP Plus Nd:YAG Family of Laser Systems (K050293) - Fotona Fidelis…
Fotona D.D.2009—
*K083889Fotona QX ND:Yag/KTP Laser System Family
Summary page 5
…y (K113702) - Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family (K093162) - Fotona XP Nd:YAG Laser System Family (K090126) - Fotona QX Nd:YAG/KTP Laser System Family (K083889) - Fotona XP Plus Nd:YAG Family of Laser Systems (K050293) - Fotona Fidelis Er:YAG Laser System & Accessories (K990243) 4. DE…
Fotona D.D.2009—
*K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…
Summary page 5
…m Family (K093162) - Fotona XP Nd:YAG Laser System Family (K090126) - Fotona QX Nd:YAG/KTP Laser System Family (K083889) - Fotona XP Plus Nd:YAG Family of Laser Systems (K050293) - Fotona Fidelis Er:YAG Laser System & Accessories (K990243) 4. DEVICE DESCRIPTION The Fotona Dynamis Pro Laser System Fami…
Fotona D.D.2005—
*K990243Fotona Fidelis ER:Yag Laser System & Accessories
Summary page 5
…90126) - Fotona QX Nd:YAG/KTP Laser System Family (K083889) - Fotona XP Plus Nd:YAG Family of Laser Systems (K050293) - Fotona Fidelis Er:YAG Laser System & Accessories (K990243) 4. DEVICE DESCRIPTION The Fotona Dynamis Pro Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser te…
Fotona D.D.1999—

Also cleared against K101306: 5 other devices →

What descends from it? (62)

See all 62

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

NumberDeviceApplicantDecidedDescendants
K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632
K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820
K171227StarWalkerFotona D.O.O.20177
K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180

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 20 years and passes through 8 companies; a new generation was cleared every 10 months on median.
  • 26 of the 539 ancestors have a recall of any class.
  • Of its descendants, K153671 (Cutera, Inc., 2016) has gone furthest, with 32 descendants of its own.
  • 5 other devices also cite its predicate K101306.

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. 2015, 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?

**Dynamis Er:YAG laser (2940 nm wavelength) The Fotona 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…

Read the full statement (553 words)

**Dynamis Er:YAG laser (2940 nm wavelength)

The Fotona 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;

· 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;

**Dynamis Nd:YAG laser (1064 nm wavelength):

The Fotona 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 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:

o Matrixectomy

o Radical nail excision

o Periungual and subungual warts

o Plantar warts

o Neuromas

o 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. “K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143723

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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