510(k) · Cleared
ClearedWavelight Sinon
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 Feb 15, 2005 as substantially equivalent to K040433 (Wavelight Laser Technologie AG, 2004) and 5 other predicates after a 15-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Feb 15, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K910422 (1992). 102 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 2 generations backK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- 1 generation backK040384 Mydon CWavelight Laser Technologie AG · 2004
- This deviceK050218 Wavelight SinonWavelight Laser Technologie AG · 2005
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 3 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 2 generations backK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- 1 generation backK040384 Mydon CWavelight Laser Technologie AG · 2004
- This deviceK050218 Wavelight SinonWavelight Laser Technologie AG · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −3 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| −2 | K032220 | Adept 1064/532 Laser | Adept Medical Concepts | 2003 | — |
| −1 | K040384 | Mydon C | Wavelight Laser Technologie AG | 2004 | — |
| 0 (this device) | K050218 | Wavelight Sinon | Wavelight Laser Technologie AG | 2005 | — |
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 | 10 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 9 | 0 |
| 2001 | 12 | 0 |
| 2002 | 13 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (6)
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 |
|---|---|---|---|
| * | K040433 | SINONSummary page 1…Panel: Dermatology and Plastic Surgery 3. Predicate Devices This submission refers to the SINON device registered under 510(k) number K040433. Therefore the SINON described here is substantially equivalent to the SINON registered under 510(k) number K040433.… | 2004 |
| * | K991285 | Laser System Rubystar with Q-Switch and Normal ModeSummary page 1…K040433. The SINON laser system is furthermore substantially equivalent to the Aesculap-Meditec RubyStar Laser System with Normal and Q-Switch Mode (K99 1285), the Spectrum Medical Technologies RD-1200 (K910422), the MLT Laser Technologies Inc. MLT R694 (K9909002), the Mehi/Bioph… | 1999 |
| * | K910422 | Model RD-1200 Ruby Laser SystemSummary page 1…substantially equivalent to the Aesculap-Meditec RubyStar Laser System with Normal and Q-Switch Mode (K99 1285), the Spectrum Medical Technologies RD-1200 (K910422), the MLT Laser Technologies Inc. MLT R694 (K9909002), the Mehi/Biophile Inc. Chromos 694 (K971814) and WaveLights… | 1992 |
| * | K990902 | Modification of MLT R694 Ruby Laser System | 1999 |
| * | K971814 | Improvements to the Mehl Ruby LaserSummary page 1…(K99 1285), the Spectrum Medical Technologies RD-1200 (K910422), the MLT Laser Technologies Inc. MLT R694 (K9909002), the Mehi/Biophile Inc. Chromos 694 (K971814) and WaveLights SINON device (K040384). 0… | 1997 |
| * | K040384 | Mydon CSummary page 1…hnologies RD-1200 (K910422), the MLT Laser Technologies Inc. MLT R694 (K9909002), the Mehi/Biophile Inc. Chromos 694 (K971814) and WaveLights SINON device (K040384). 0 021… | 2004 |
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 13 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 3 of the 102 ancestors have a recall of any class.
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. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue.
This includes the removal of tattoos and treatment of benign pigmented lesions.
2. In the Free-Running Mode, for the removal of unwanted hair in patients with
Fitzpatrick skin types of I and II.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050218: Wavelight Sinon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050218
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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