510(k) · Cleared
ClearedAurora
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premier Laser Systems, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Nov 23, 1998 after a 221-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 281 later devices descend from it.
- Decided
- Nov 23, 1998
- Review
- 221 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
281 later devices descend from it, 2 citing it directly.
- This deviceK981379 AuroraPremier Laser Systems, Inc. · 1998
- Descendant · cites it directly · 280 of its ownK991994 TwilightBiolase Technology, Inc. · 1999
- Descendant · cites it directly · 246 of its ownK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
- Descendant · 2 generations on · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
- Descendant · 3 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 4 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Showing 5 of 281 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 281 · See all- K991994TwilightBiolase Technology, Inc. · 1999 · cites it directly280descendants
- K012511Waterlase MillenniumBiolase Technology, Inc. · 2002 · cites it directly246descendants
- K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · 2 generations on240descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 3 generations on226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 4 generations on221descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981379 | Aurora | Premier Laser Systems, Inc. | 1998 | — |
| +1 | K991994 | Twilight | Biolase Technology, Inc. | 1999 | — |
| +1 | K012511 | Waterlase Millennium | Biolase Technology, Inc. | 2002 | — |
| +2 | K021508 | Opusduo EC Dental Laser System | Opusdent, Ltd. | 2002 | — |
| +3 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +4 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 14 | 0 |
| 2009 | 5 | 0 |
| 2010 | 11 | 0 |
| 2011 | 8 | 0 |
| 2012 | 5 | 0 |
| 2013 | 11 | 0 |
| 2014 | 11 | 0 |
| 2015 | 13 | 0 |
| 2016 | 11 | 0 |
| 2017 | 9 | 0 |
| 2018 | 15 | 0 |
| 2019 | 8 | 0 |
| 2020 | 17 | 0 |
| 2021 | 12 | 0 |
| 2022 | 26 | 0 |
| 2023 | 15 | 0 |
| 2024 | 26 | 0 |
| 2025 | 32 | 0 |
| 2026 | 19 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (281)
See all 2812 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, K991994 (Biolase Technology, Inc., 1999) has gone furthest, with 280 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?
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
NOTE: This is an additional indication to the indications cleared for market Release in 510(k) 954316.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981379: Aurora.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981379
Report an extraction error
Are you the manufacturer?
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