510(k) · Cleared
ClearedKey Laser Iii 1243 US with Detect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kavo America · GEX Powered Laser Surgical Instrument
Cleared on Jul 10, 2008 as substantially equivalent to K030146 (Kavo America, 2005) and 4 other predicates after a 253-day review. Its family tree reaches back 4 generations to 1998. 26 later devices descend from it.
- Decided
- Jul 10, 2008
- Review
- 253 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to DEN980003 (1998). 8 ancestors in all. 26 later devices descend from it, 1 citing it directly.
- Root · 4 generations backDEN980003 Diamond Probe/Perio 2000 SystemDiamond General Development Corp. · 1998
- 3 generations backK023367 Detectar, Model N123-MINeks Technologies · 2003
- 2 generations backK042394 Diagnodent Perio Tip (Accessory)Kavo America Corporation · 2005
- 1 generation backK060080 Diagnodent 2190 with Periodontal ProbeKavo Dental Corporation · 2006
- This deviceK073074 Key Laser Iii 1243 US with DetectKavo America · 2008
- Descendant · cites it directly · 25 of its ownK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 21 of its ownK161669 Waterlase ExpressBiolase, Inc. · 2016
- Descendant · 2 generations on · 19 of its ownK190319 Waterlase Laser System FamilyBiolase, Inc. · 2019
- Descendant · 3 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · 3 generations on · 8 of its ownK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · cites it directly25descendants
- K161669Waterlase ExpressBiolase, Inc. · 2016 · 2 generations on21descendants
- K190319Waterlase Laser System FamilyBiolase, Inc. · 2019 · 2 generations on19descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 3 generations on11descendants
- K193661LightWalker Laser System FamilyFotona D.O.O. · 2020 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN980003 | Diamond Probe/Perio 2000 System | Diamond General Development Corp. | 1998 | — |
| −3 | K023367 | Detectar, Model N123-MI | Neks Technologies | 2003 | — |
| −2 | K042394 | Diagnodent Perio Tip (Accessory) | Kavo America Corporation | 2005 | — |
| −1 | K060080 | Diagnodent 2190 with Periodontal Probe | Kavo Dental Corporation | 2006 | — |
| 0 (this device) | K073074 | Key Laser Iii 1243 US with Detect | Kavo America | 2008 | — |
| +1 | K101658 | Waterlase MD Turbo Plus Model 7200XXX | Biolase Technology, Inc. | 2010 | 1 |
| +2 | K161669 | Waterlase Express | Biolase, Inc. | 2016 | — |
| +2 | K190319 | Waterlase Laser System Family | Biolase, Inc. | 2019 | — |
| +3 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +3 | K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (5)
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 |
|---|---|---|---|
| * | K030146 | Kavo Key Laser 1242 and Kavo Key Laser 1243+Summary page 1…Caries Detection Device, Product Code NTK Common/Usual Name: Surgical laser with laser fluorescence caries detection device 2. Equivalent legally marketed device: K030146 Kavo Key Laser combined with K983658/ K042394/ K051909/ K060080 (Diagnodent®) Indications for Use (intended use): For remo… | 2005 |
| * | DEN990002 | Kavo Diagnodent Our reading of the summary gave K983658, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN990002, Kavo Diagnodent (Kavo America), granted Feb 22, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2000 |
| * | K042394 | Diagnodent Perio Tip (Accessory)Summary page 1…ommon/Usual Name: Surgical laser with laser fluorescence caries detection device 2. Equivalent legally marketed device: K030146 Kavo Key Laser combined with K983658/ K042394/ K051909/ K060080 (Diagnodent®) Indications for Use (intended use): For removal of subgingival calculi in periodontal pockets… | 2005 |
| * | K051909 | DiagnodentSummary page 1…al Name: Surgical laser with laser fluorescence caries detection device 2. Equivalent legally marketed device: K030146 Kavo Key Laser combined with K983658/ K042394/ K051909/ K060080 (Diagnodent®) Indications for Use (intended use): For removal of subgingival calculi in periodontal pockets with… | 2005 |
| * | K060080 | Diagnodent 2190 with Periodontal ProbeSummary page 1…Surgical laser with laser fluorescence caries detection device 2. Equivalent legally marketed device: K030146 Kavo Key Laser combined with K983658/ K042394/ K051909/ K060080 (Diagnodent®) Indications for Use (intended use): For removal of subgingival calculi in periodontal pockets with periodont… | 2006 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101658 | Waterlase MD Turbo Plus Model 7200XXX | 2010 | 25 |
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?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K101658 (Biolase Technology, Inc., 2010) has gone furthest, with 25 descendants of its own.
- 2 other devices also cite its predicate K030146.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
For removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage.
Removal of subgingival calculi in periodontal pockets which have been affected by periodontitis, with open or closed curettage and using the detection function of the KEY Laser 1243..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073074: Key Laser Iii 1243 US with Detect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073074
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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