510(k) · Cleared
ClearedLaseaway Q-Switched Ruby Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polytec Pi, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 8, 1994 after a 53-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 40 later devices descend from it.
- Decided
- Jul 8, 1994
- Review
- 53 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 1 citing it directly.
- This deviceK942343 Laseaway Q-Switched Ruby Laser SystemPolytec Pi, Inc. · 1994
- Descendant · cites it directly · 39 of its ownK971193 Laseaway Long Pulse and Q-Switched Ruby Laser SystemPolytec Pi, Inc. · 1997
- Descendant · 2 generations on · 38 of its ownK121162 Polaris Q-Switch Ruby SystemSandstone Medical Technologies, LLC · 2012
- Descendant · 3 generations on · 37 of its ownK152012 EVO platformQuanta System Spa · 2015
- Descendant · 4 generations on · 36 of its ownK160368 EVO platformQuanta System Spa · 2016
- Descendant · 5 generations on · 30 of its ownK163222 Discovery Pico FamilyQuanta System Spa · 2016
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K971193Laseaway Long Pulse and Q-Switched Ruby Laser SystemPolytec Pi, Inc. · 1997 · cites it directly39descendants
- K121162Polaris Q-Switch Ruby SystemSandstone Medical Technologies, LLC · 2012 · 2 generations on38descendants
- K152012EVO platformQuanta System Spa · 2015 · 3 generations on37descendants
- K160368EVO platformQuanta System Spa · 2016 · 4 generations on36descendants
- K163222Discovery Pico FamilyQuanta System Spa · 2016 · 5 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942343 | Laseaway Q-Switched Ruby Laser System | Polytec Pi, Inc. | 1994 | — |
| +1 | K971193 | Laseaway Long Pulse and Q-Switched Ruby Laser System | Polytec Pi, Inc. | 1997 | — |
| +2 | K121162 | Polaris Q-Switch Ruby System | Sandstone Medical Technologies, LLC | 2012 | — |
| +3 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| +4 | K160368 | EVO platform | Quanta System Spa | 2016 | — |
| +5 | K163222 | Discovery Pico Family | Quanta System Spa | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 11 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971193 | Laseaway Long Pulse and Q-Switched Ruby Laser System | 1997 | 39 |
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, K971193 (Polytec Pi, Inc., 1997) has gone furthest, with 39 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 | — |
https://510kreport.com/device/K942343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942343: Laseaway Q-Switched Ruby Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942343
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026