510(k) · Cleared
ClearedLaser System Rubystar with Q-Switch and Normal Mode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap-Meditec North America · GEX Powered Laser Surgical Instrument
Cleared on Jul 12, 1999 after an 88-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jul 12, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK991285 Laser System Rubystar with Q-Switch and Normal ModeAesculap-Meditec North America · 1999
- Descendant · cites it directly · 1 of its ownK040433 SINONWavelight Laser Technologie AG · 2004
- Descendant · cites it directly · 0 of its ownK050218 Wavelight SinonWavelight Laser Technologie AG · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991285 | Laser System Rubystar with Q-Switch and Normal Mode | Aesculap-Meditec North America | 1999 | — |
| +1 | K040433 | SINON | Wavelight Laser Technologie AG | 2004 | — |
| +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 |
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? (8)
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 |
|---|---|---|---|
| * | — | MLT R694 Named without a submission number | |
| * | — | 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 | |
| * | — | EpiLaser Named without a submission number | |
| * | — | Chromos 694 Named without a submission number | |
| * | — | Sharplan EpiTouch Named without a submission number |
What descends from it? (2)
2 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?
- 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 laser system Ruby Star (operating in normal use) is intended to remove unwanted body hair.
The laser system Ruby Star (operating in Q-Switch mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.
Some examples of pigment lesions are:
Lentigines, Cafe-au-lait-blotches, Ephalides, Benign Naevi such as Nevus of Ota, Naevus of Ito, Epidermal naevi, Congenital naevi, Becker’s naevi, Blue naevus, Naevus spilus, and Mongolian spot.
The laser system Ruby Star is restricted to sale 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/K991285 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991285: Laser System Rubystar with Q-Switch and Normal Mode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991285
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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