510(k) · Cleared
ClearedARAGO
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 Dec 16, 1997 after a 270-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 16, 1997
- Review
- 270 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK971118 ARAGOPremier Laser Systems, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK983654 Cyber-Lase 2000 Curing and Whitening LaserIcs of North America, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K983654Cyber-Lase 2000 Curing and Whitening LaserIcs of North America, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971118 | ARAGO | Premier Laser Systems, Inc. | 1997 | — |
| +1 | K983654 | Cyber-Lase 2000 Curing and Whitening Laser | Ics of North America, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983654 | Cyber-Lase 2000 Curing and Whitening Laser | 1999 | 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, K983654 (Ics of North America, Inc., 1999) has gone furthest, with 0 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?
1. Curing of all light cured bonding materials. 2. Curing of pit and fissure sealants (unfilled resins). 3. Curing for all classes of composite restorations (filled resins). 4 Curing for endodontic composite cores. 5. Curing composite cements for porcelain facings and inlays. 6. Curing of light activated periodontal splint material. 7. Curing of light activated prosthetic reline and repair material. 8. Curing used in the fabrication of laboratory…
Read the full statement (105 words)
1. Curing of all light cured bonding materials.
2. Curing of pit and fissure sealants (unfilled resins).
3. Curing for all classes of composite restorations (filled resins).
4 Curing for endodontic composite cores.
5. Curing composite cements for porcelain facings and inlays.
6. Curing of light activated periodontal splint material.
7. Curing of light activated prosthetic reline and repair material.
8. Curing used in the fabrication of laboratory indirect light activated restorations
and provisional restorations.
9. Illumination purposes for the adjunctive use in caries detection.
10. Tllumination purposes for the adjunctive use for endodontic orifice location.
11. Light activation for bleaching materials for teeth whitening.
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/K971118 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971118: ARAGO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971118
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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