510(k) · Cleared
ClearedMydon C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wavelight Laser Technologie AG · GEX Powered Laser Surgical Instrument
Cleared on May 14, 2004 as substantially equivalent to K023954 (Altus Medical, Inc., 2003) and 3 other predicates after an 87-day review. Its family tree reaches back 8 generations to 1992. 51 later devices descend from it.
- Decided
- May 14, 2004
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K910422 (1992). 96 ancestors in all, the oldest K820106 (1982). 51 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 4 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 3 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 2 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 1 generation backK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- This deviceK040384 Mydon CWavelight Laser Technologie AG · 2004
- Descendant · cites it directly · 46 of its ownK090762 LEDAQuantel Derma GmbH · 2009
- Descendant · 2 generations on · 24 of its ownK200104 OxylightRaja Trading Company, Inc. · 2020
- Descendant · 3 generations on · 16 of its ownK240089 Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- Descendant · 3 generations on · 11 of its ownK222751 LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023
- Descendant · 2 generations on · 9 of its ownK150752 GME ExSys 308Gme (German Medical Engineering) GmbH · 2015
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K090762LEDAQuantel Derma GmbH · 2009 · cites it directly46descendants
- K200104OxylightRaja Trading Company, Inc. · 2020 · 2 generations on24descendants
- K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · 3 generations on16descendants
- K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023 · 3 generations on11descendants
- K150752GME ExSys 308Gme (German Medical Engineering) GmbH · 2015 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −7 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −5 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −4 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −3 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −2 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| −1 | K032220 | Adept 1064/532 Laser | Adept Medical Concepts | 2003 | — |
| 0 (this device) | K040384 | Mydon C | Wavelight Laser Technologie AG | 2004 | — |
| +1 | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| +2 | K200104 | Oxylight | Raja Trading Company, Inc. | 2020 | — |
| +3 | K240089 | Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| +3 | K222751 | LED Light Therapy Device, KN-7000L | Xuzhou Kernel Medical Equipment Co., Ltd. | 2023 | — |
| +2 | K150752 | GME ExSys 308 | Gme (German Medical Engineering) GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 12 | 0 |
| 2002 | 13 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 15 | 0 |
| 2026 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary page 1…logy and Plastic Surgery 3. Predicate Devices The MYDON C laser system is substantially equivalent to the Altus Medical CoolGlide Aesthetics Laser (K023954), the Laserscope Lyra Surgical Laser System (K02002 1), the Fotona DUALIS XP Plus Nd:YAG Laser System (K022839) and the… | 2003 |
| * | K020021 | Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Summary page 1…he MYDON C laser system is substantially equivalent to the Altus Medical CoolGlide Aesthetics Laser (K023954), the Laserscope Lyra Surgical Laser System (K02002 1), the Fotona DUALIS XP Plus Nd:YAG Laser System (K022839) and the Adept Medical Concepts 1064/532 Laser (K032220).… | 2002 |
| * | K022839 | Fotona Dualis Plus ND:Yag Laser SystemSummary page 1…Altus Medical CoolGlide Aesthetics Laser (K023954), the Laserscope Lyra Surgical Laser System (K02002 1), the Fotona DUALIS XP Plus Nd:YAG Laser System (K022839) and the Adept Medical Concepts 1064/532 Laser (K032220). 4. Device Description The MYDON C is a 1064 nm s… | 2002 |
| * | K032220 | Adept 1064/532 LaserSummary page 1…Laserscope Lyra Surgical Laser System (K02002 1), the Fotona DUALIS XP Plus Nd:YAG Laser System (K022839) and the Adept Medical Concepts 1064/532 Laser (K032220). 4. Device Description The MYDON C is a 1064 nm solid-state long-pulsed Nd:YAG laser system. The beam is… | 2003 |
What descends from it? (51)
See all 513 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 12 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 96 ancestors have a recall of any class.
- Of its descendants, K090762 (Quantel Derma GmbH, 2009) has gone furthest, with 46 descendants of its own.
- 18 other devices also cite its predicate K023954.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins. 2. The MYDON C laser system is also indicated for the treatment of wrinkles. 3. The MYDON C is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB). 4. The MYDON C laser system is indicated for use on all…
Read the full statement (146 words)
1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
2. The MYDON C laser system is also indicated for the treatment of wrinkles.
3. The MYDON C is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
4. The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
5. The intended use of the integral cooling system in the MYDON C laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatuents such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040384 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040384: Mydon C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040384
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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