510(k) · Cleared
ClearedModification of MLT R694 Ruby Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Laser Technologies, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on May 27, 1999 as substantially equivalent to K980187 (Medical Laser Technologies, Ltd., 1998) after a 70-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.
- Decided
- May 27, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980187 (1998). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK980187 MLT R694 Ruby Laser SystemMedical Laser Technologies, Ltd. · 1998
- This deviceK990902 Modification of MLT R694 Ruby Laser SystemMedical Laser Technologies, Ltd. · 1999
- Descendant · cites it directly · 1 of its ownK040433 SINONWavelight Laser Technologie AG · 2004
- Descendant · cites it directly · 0 of its ownK150997 Ruby StarBison Medical Co, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK050218 Wavelight SinonWavelight Laser Technologie AG · 2005
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980187 | MLT R694 Ruby Laser System | Medical Laser Technologies, Ltd. | 1998 | — |
| 0 (this device) | K990902 | Modification of MLT R694 Ruby Laser System | Medical Laser Technologies, Ltd. | 1999 | — |
| +1 | K040433 | SINON | Wavelight Laser Technologie AG | 2004 | — |
| +1 | K150997 | Ruby Star | Bison Medical Co, Ltd. | 2015 | — |
| +1 | K050218 | Wavelight Sinon | Wavelight Laser Technologie AG | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K980187 | MLT R694 Ruby Laser SystemSummary page 1…de the beam has a much shorter pulse duration than in the normal or long pulse mode. The specifications for the normal or long pulse mode remain the same as described in K980187. 0 o Intended Use: The MLT R694 Ruby Laser System in the Q-Switched mode is indicated for cutting, vaporization,… | 1998 |
| * | — | LaseAway Long Pulse and Q-Switched Ruby Laser Named without a submission number | |
| * | — | MM-Ruby Laser Named without a submission number | |
| * | — | Spectrum RD 1200 Named without a submission number | |
| * | — | Candela AlexLAZR Named without a submission number |
What descends from it? (3)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K040433 (Wavelight Laser Technologie AG, 2004) has gone furthest, with 1 descendant of its own.
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?
The MLT R694 Ruby Laser System (operating in the Q-Switched mode) is indicated for
cutting, vaporization, or ablation of soft tissue. This includes tatoo removal and treatment
of benign pigmented lesions.
The MLT R694 Ruby Laser System is restricted to sale to or use by licensed professionals
in the United States
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/K990902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990902: Modification of MLT R694 Ruby Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990902
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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