510(k) · Cleared
ClearedSINON
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 19, 2004 as substantially equivalent to K991285 (Aesculap-Meditec North America, 1999) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- May 19, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K980187 (1998). 5 ancestors in all, the oldest K910422 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK980187 MLT R694 Ruby Laser SystemMedical Laser Technologies, Ltd. · 1998
- 1 generation backK990902 Modification of MLT R694 Ruby Laser SystemMedical Laser Technologies, Ltd. · 1999
- This deviceK040433 SINONWavelight Laser Technologie AG · 2004
- Descendant · cites it directly · 0 of its ownK050218 Wavelight SinonWavelight Laser Technologie AG · 2005
Most influential descendants
Showing 1 of 1 · See all- K050218Wavelight SinonWavelight Laser Technologie AG · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980187 | MLT R694 Ruby Laser System | Medical Laser Technologies, Ltd. | 1998 | — |
| −1 | K990902 | Modification of MLT R694 Ruby Laser System | Medical Laser Technologies, Ltd. | 1999 | — |
| 0 (this device) | K040433 | SINON | Wavelight Laser Technologie AG | 2004 | — |
| +1 | K050218 | Wavelight Sinon | Wavelight Laser Technologie AG | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (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 |
|---|---|---|---|
| * | K991285 | Laser System Rubystar with Q-Switch and Normal ModeSummary page 1…3. Predicate Devices The SINON laser system is substantially equivalent to the Aesculap-Meditec RubyStar Laser System with Normal and Q-Switch Mode (K99 1285), the Spectrum Medical Technologies RD- 1200 (K9 10422), the MLT Laser Technologies Inc. MLT R694 (K9909002) and th… | 1999 |
| * | K910422 | Model RD-1200 Ruby Laser SystemSummary page 1…ubstantially equivalent to the Aesculap-Meditec RubyStar Laser System with Normal and Q-Switch Mode (K99 1285), the Spectrum Medical Technologies RD- 1200 (K9 10422), the MLT Laser Technologies Inc. MLT R694 (K9909002) and the Mehl/Biophile Inc. Chromos 694 (K9718 14). 4. De… | 1992 |
| * | K990902 | Modification of MLT R694 Ruby Laser System Our reading of the summary gave K990900, FDA’s number for Microkeratome, Model MK-2000 (Nidek, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MLT Laser Technologies Inc. MLT R694”. | 1999 |
| * | K971814 | Improvements to the Mehl Ruby LaserSummary page 1…, the Spectrum Medical Technologies RD- 1200 (K9 10422), the MLT Laser Technologies Inc. MLT R694 (K9909002) and the Mehl/Biophile Inc. Chromos 694 (K9718 14). 4. Device Description The SINON is a 694 nm Ruby laser system which can be operated intwo different modes.… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050218 | Wavelight Sinon | 2005 | 0 |
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 6 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K050218 (Wavelight Laser Technologie AG, 2005) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K991285.
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/K040433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040433: SINON.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040433
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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