510(k) · Cleared
ClearedSP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
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 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.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 2 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 1 generation backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- This deviceK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · cites it directly · 32 of its ownK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- Descendant · 2 generations on · 24 of its ownK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- Descendant · 3 generations on · 22 of its ownK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- Descendant · cites it directly · 20 of its ownK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- Descendant · 4 generations on · 14 of its ownK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 8 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 7 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 6 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 3 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 2 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 1 generation backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −8 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −7 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −6 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −3 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −1 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| 0 (this device) | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +1 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
| +2 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology… | Alma Lasers, Inc. | 2017 | — |
| +3 | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| +1 | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | 2018 | — |
| +4 | K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 9 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 27 | 0 |
| 1995 | 26 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 33 | 0 |
| 1999 | 28 | 0 |
| 2000 | 36 | 0 |
| 2001 | 34 | 0 |
| 2002 | 42 | 0 |
| 2003 | 47 | 0 |
| 2004 | 34 | 0 |
| 2005 | 28 | 0 |
| 2006 | 17 | 0 |
| 2007 | 17 | 0 |
| 2008 | 19 | 0 |
| 2009 | 10 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 11 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K101306 | SP 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… | 2011 |
| * | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceSummary 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… | 2014 |
| * | K113702 | Fotona XP ND: Yag Laser SystemSummary 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… | 2012 |
| * | K093162 | Fidelis 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… | 2010 |
| * | K090126 | Fotona 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… | 2009 |
| * | K083889 | Fotona QX ND:Yag/KTP Laser System FamilySummary 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… | 2009 |
| * | K050293 | Fotona 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… | 2005 |
| * | K990243 | Fotona Fidelis ER:Yag Laser System & AccessoriesSummary 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… | 1999 |
What descends from it? (62)
See all 624 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 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 devicesGEX 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
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?
**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.
https://510kreport.com/device/K143723 · printed Nov 6, 2026
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