510(k) · Cleared
ClearedDynamis Pro Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fotona D.O.O. · GEX Powered Laser Surgical Instrument
Cleared on Sep 8, 2022 as substantially equivalent to K202985 (Fotona D.O.O., 2021) and 1 other predicate after a 343-day review. Its family tree reaches back 24 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 8, 2022
- Review
- 343 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 24 generations to K943450 (1995). 568 ancestors in all, the oldest K771218 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations between
- 3 generations backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- 2 generations backK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- 1 generation backK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- This deviceK213267 Dynamis Pro FamilyFotona D.O.O. · 2022
- Descendant · cites it directly · 0 of its ownK252723 Dynamis Pro FamilyFotona D.O.O. · 2026
- Descendant · cites it directly · 0 of its ownK223540 AvalancheLase FamilyFotona D.O.O. · 2023
Show all 24 generations
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 20 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 19 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 18 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 17 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 16 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 13 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 12 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 11 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 10 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 9 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 8 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 7 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 6 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 5 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 4 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 3 generations backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- 2 generations backK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- 1 generation backK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- This deviceK213267 Dynamis Pro FamilyFotona D.O.O. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −23 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −20 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −19 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −18 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −17 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −16 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −13 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −12 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −11 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −10 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −9 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −8 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −7 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −6 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −5 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −4 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −3 | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | 2018 | — |
| −2 | K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020 | — |
| −1 | K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021 | — |
| 0 (this device) | K213267 | Dynamis Pro Family | Fotona D.O.O. | 2022 | — |
| +1 | K252723 | Dynamis Pro Family | Fotona D.O.O. | 2026 | — |
| +1 | K223540 | AvalancheLase Family | Fotona D.O.O. | 2023 | — |
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 | 35 | 0 |
| 1999 | 28 | 0 |
| 2000 | 38 | 0 |
| 2001 | 35 | 0 |
| 2002 | 42 | 0 |
| 2003 | 48 | 0 |
| 2004 | 36 | 0 |
| 2005 | 32 | 0 |
| 2006 | 18 | 0 |
| 2007 | 17 | 0 |
| 2008 | 21 | 0 |
| 2009 | 13 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K202985 | LightWalker Laser System FamilySummary page 5…al Instrument, General and Plastic Surgery 21 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICE LightWalker Laser System Family (K202985) Dynamis Pro Family (K182088) DEVICE DESCRIPTION SUMMARY The Dynamis Pro Family is based on Er:YAG (2940 nm) and Nd:YAG (1064… | 2021 |
| * | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroSummary page 5…astic Surgery 21 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICE LightWalker Laser System Family (K202985) Dynamis Pro Family (K182088) DEVICE DESCRIPTION SUMMARY The Dynamis Pro Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The las… | 2018 |
What descends from it? (2)
2 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 27 years and passes through 9 companies; a new generation was cleared every 12 months on median.
- 29 of the 568 ancestors have a recall of any class.
- Of its descendants, K252723 (Fotona D.O.O., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K202985.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
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 (606 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;
- Uvulopalatoplasty by laser resurfacing
- 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 and X-Restart Handpieces are 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 - VL.
- 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-V], 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.
Nd:YAG laser (1064 nm wavelength) therapy:
- Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213267: Dynamis Pro Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213267
Report an extraction error
Are you the manufacturer?
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