510(k) · Cleared
ClearedAvalancheLase 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 Jan 19, 2023 as substantially equivalent to K213267 (Fotona D.O.O., 2022) and 4 other predicates after a 55-day review. Its family tree reaches back 25 generations to 1995.
- Decided
- Jan 19, 2023
- Review
- 55 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 25 generations to K943450 (1995). 587 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations between
- 3 generations backK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- 2 generations backK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- 1 generation backK213267 Dynamis Pro FamilyFotona D.O.O. · 2022
- This deviceK223540 AvalancheLase FamilyFotona D.O.O. · 2023
Show all 25 generations
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 24 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 21 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 20 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 19 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 18 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 17 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 14 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 13 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 12 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 11 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 10 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 9 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 8 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 7 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 6 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 5 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 4 generations backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- 3 generations backK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- 2 generations backK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- 1 generation backK213267 Dynamis Pro FamilyFotona D.O.O. · 2022
- This deviceK223540 AvalancheLase FamilyFotona D.O.O. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −24 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −21 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −20 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −19 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −18 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −17 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −14 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −13 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −12 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −11 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −10 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −9 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −8 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −7 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −6 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −5 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −4 | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | 2018 | — |
| −3 | K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020 | — |
| −2 | K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021 | — |
| −1 | K213267 | Dynamis Pro Family | Fotona D.O.O. | 2022 | — |
| 0 (this device) | 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 | 49 | 0 |
| 2004 | 36 | 0 |
| 2005 | 32 | 0 |
| 2006 | 19 | 0 |
| 2007 | 17 | 0 |
| 2008 | 21 | 0 |
| 2009 | 15 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 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? (5)
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 |
|---|---|---|---|
| * | K213267 | Dynamis Pro FamilySummary page 5…se In General And Plastic Surgery And In Dermatology (21 CFR 878.4810; Class II) Product Code: GEX PREDICATE DEVICES Dynamis Pro Family (K213267) Family of CoolGlide Aesthetic Lasers (K153671) GentleMAX Family of Laser Systems (K201111) GentleLASE Family of Laser Systems (K… | 2022 |
| * | K153671 | Family of CoolGlide Aesthetic LasersSummary page 5…And In Dermatology (21 CFR 878.4810; Class II) Product Code: GEX PREDICATE DEVICES Dynamis Pro Family (K213267) Family of CoolGlide Aesthetic Lasers (K153671) GentleMAX Family of Laser Systems (K201111) GentleLASE Family of Laser Systems (K140732) DEKA MOTUS AX (K162886) DEVICE DESCRI… | 2016 |
| * | K201111 | GentleMax Pro PlusSummary page 5…0; Class II) Product Code: GEX PREDICATE DEVICES Dynamis Pro Family (K213267) Family of CoolGlide Aesthetic Lasers (K153671) GentleMAX Family of Laser Systems (K201111) GentleLASE Family of Laser Systems (K140732) DEKA MOTUS AX (K162886) DEVICE DESCRIPTION SUMMARY The AvalancheLase Family is b… | 2020 |
| * | K140732 | Candela Gentlelase Family of Laser SystemsSummary page 5…ICATE DEVICES Dynamis Pro Family (K213267) Family of CoolGlide Aesthetic Lasers (K153671) GentleMAX Family of Laser Systems (K201111) GentleLASE Family of Laser Systems (K140732) DEKA MOTUS AX (K162886) DEVICE DESCRIPTION SUMMARY The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755… | 2014 |
| * | K162886 | Deka Motus AXSummary page 5…o Family (K213267) Family of CoolGlide Aesthetic Lasers (K153671) GentleMAX Family of Laser Systems (K201111) GentleLASE Family of Laser Systems (K140732) DEKA MOTUS AX (K162886) DEVICE DESCRIPTION SUMMARY The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 nm) laser technology. T… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 9 companies; a new generation was cleared every 11 months on median.
- 29 of the 587 ancestors have a recall of any class.
- 1 other device also cites its predicate K213267.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The AvalancheLase Family and its accessories will be marketed for the following indications for use: Alexandrite laser (755 nm wavelength): Indications in Dermatology and Aesthetics • Temporary hair reduction. • Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair…
Read the full statement (372 words)
The AvalancheLase Family and its accessories will be marketed for the following indications for use:
Alexandrite laser (755 nm wavelength):
Indications in Dermatology and Aesthetics
• Temporary hair reduction.
• Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin.
• Treatment of benign pigmented lesions.
• Treatment of wrinkles
• The photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG laser (1064 nm wavelength):
The Nd:YAG laser module 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.
Indications in Dermatology and Aesthetics:
• 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 (LX Runner) 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.)
NNd: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 as stated in the FDA summary.
https://510kreport.com/device/K223540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223540: AvalancheLase Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223540
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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