510(k) · Cleared
ClearedOrion Series Surgical Laser System (SL Seriesq-Switched ND:Yag Configuration)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laserscope · GEX Powered Laser Surgical Instrument
Cleared on Mar 8, 2000 after a 370-day review. The FDA summary names no predicate by number. 745 later devices descend from it.
- Decided
- Mar 8, 2000
- Review
- 370 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
745 later devices descend from it, 6 citing it directly.
- This deviceK990718 Orion Series Surgical Laser System (SL Seriesq-Switched ND:Yag…Laserscope · 2000
- Descendant · cites it directly · 739 of its ownK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- Descendant · 2 generations on · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- Descendant · 2 generations on · 656 of its ownK022923 Candela Gentle Yag Laser SystemCandela Corp. · 2003
- Descendant · 2 generations on · 656 of its ownK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- Descendant · 3 generations on · 654 of its ownK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
Showing 5 of 745 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 745 · See all- K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc. · 2002 · cites it directly739descendants
- K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · 2 generations on665descendants
- K022923Candela Gentle Yag Laser SystemCandela Corp. · 2003 · 2 generations on656descendants
- K023193Candela Gentle Yag Laser SystemCandela Corp. · 2002 · 2 generations on656descendants
- K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003 · 3 generations on654descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990718 | Orion Series Surgical Laser System (SL Seriesq-Switched ND:Yag Configuration) | Laserscope | 2000 | — |
| +1 | 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 | — |
| +2 | K022923 | Candela Gentle Yag Laser System | Candela Corp. | 2003 | — |
| +2 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| +3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 16 | 0 |
| 2008 | 26 | 0 |
| 2009 | 16 | 0 |
| 2010 | 19 | 0 |
| 2011 | 25 | 0 |
| 2012 | 22 | 0 |
| 2013 | 29 | 0 |
| 2014 | 32 | 0 |
| 2015 | 27 | 0 |
| 2016 | 39 | 0 |
| 2017 | 33 | 0 |
| 2018 | 33 | 0 |
| 2019 | 24 | 0 |
| 2020 | 42 | 0 |
| 2021 | 32 | 0 |
| 2022 | 54 | 0 |
| 2023 | 42 | 0 |
| 2024 | 71 | 0 |
| 2025 | 84 | 0 |
| 2026 | 47 | 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?
The FDA summary names no predicate by number.
What descends from it? (745)
See all 7456 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and… | 2002 | 739 |
| K020697 | Depilase Twin Yag Laser System | 2002 | 229 |
| K023881 | Profile 1064 Laser System | 2003 | 227 |
| K020412 | Depilase Twin Lase Laser System | 2002 | 106 |
| K020463 | Depilase Yag Lase Plus Laser System | 2002 | 1 |
| K030508 | Depilase Trio Lase Laser System | 2003 | 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?
- Of its descendants, K014040 (Altus Medical, Inc., 2002) has gone furthest, with 739 descendants 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 Orion Series Surgical Laser System and the Lyra Surgical Laser System are intended for the lightening and removal of unwanted body hair in Fitzpatrick Skin Ty
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/K990718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990718: Orion Series Surgical Laser System (SL Seriesq-Switched ND:Yag Configuration).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990718
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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