510(k) · Cleared
ClearedMetalaser Vasculase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metatech Corp. · GEX Powered Laser Surgical Instrument
Cleared on Nov 4, 1988 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 315 later devices descend from it.
- Decided
- Nov 4, 1988
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
315 later devices descend from it, 2 citing it directly.
- This deviceK883541 Metalaser VasculaseMetatech Corp. · 1988
- Descendant · cites it directly · 307 of its ownK964074 Diolite 532Iriderm Div. · 1997
- Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 92 of its ownK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 92 of its ownK020071 Viridis Derma LaserQuantel Medical · 2002
Showing 5 of 315 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 315 · See all- K964074Diolite 532Iriderm Div. · 1997 · cites it directly307descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
- K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · 3 generations on92descendants
- K020071Viridis Derma LaserQuantel Medical · 2002 · 2 generations on92descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883541 | Metalaser Vasculase | Metatech Corp. | 1988 | — |
| +1 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| +2 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| +2 | K020071 | Viridis Derma Laser | Quantel Medical | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 11 | 0 |
| 2014 | 17 | 0 |
| 2015 | 13 | 0 |
| 2016 | 17 | 0 |
| 2017 | 18 | 0 |
| 2018 | 15 | 0 |
| 2019 | 15 | 0 |
| 2020 | 18 | 0 |
| 2021 | 17 | 0 |
| 2022 | 32 | 0 |
| 2023 | 15 | 0 |
| 2024 | 33 | 0 |
| 2025 | 35 | 0 |
| 2026 | 24 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (315)
See all 3152 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, K964074 (Iriderm Div., 1997) has gone furthest, with 307 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/K883541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K883541: Metalaser Vasculase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K883541
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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