510(k) · Cleared
ClearedCyber-Lase 2000 Curing and Whitening Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ics of North America, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 12, 1999 as substantially equivalent to K971118 (Premier Laser Systems, Inc., 1997) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jan 12, 1999
- Review
- 85 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K961682 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK961682 Argon Curing LaserPremier Laser Systems, Inc. · 1996
- This deviceK983654 Cyber-Lase 2000 Curing and Whitening LaserIcs of North America, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961682 | Argon Curing Laser | Premier Laser Systems, Inc. | 1996 | — |
| 0 (this device) | K983654 | Cyber-Lase 2000 Curing and Whitening Laser | Ics of North America, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 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? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971118 | ARAGOSummary page 1…ies. X. Substantial Equivalence: The CYBER-LASE 2000™ is substantially equivalent to lasers cleared by Premier Laser Systems, Inc., as the product, "Arago” under 510(k) K971118, and other Premier lasers including Argon Curing Laser cleared under K961682. It also is equivalent to similar lasers cleared by… | 1997 |
| * | K961682 | Argon Curing LaserSummary page 1…alent to lasers cleared by Premier Laser Systems, Inc., as the product, "Arago” under 510(k) K971118, and other Premier lasers including Argon Curing Laser cleared under K961682. It also is equivalent to similar lasers cleared by other laser companies such as LaserMed, Inc. (Accucure 1000, cleared under K9… | 1996 |
| * | K970637 | Accucure 1000Summary page 1…g Argon Curing Laser cleared under K961682. It also is equivalent to similar lasers cleared by other laser companies such as LaserMed, Inc. (Accucure 1000, cleared under K970637) and American Medical laser. The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum… | 1997 |
| * | — | American Medical laser Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
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?
This device is intended for use in:
1. Source of illumination for curing dental restorative materials,
2. Assisting in the whitening process in dental office.
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/K983654 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983654: Cyber-Lase 2000 Curing and Whitening Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983654
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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