510(k) · Cleared
ClearedCeralas Diode Laser System, Model Ceralas D15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceram Optec, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 24, 1999 as substantially equivalent to K983058 (Ceram Optec, Inc., 1998) after a 21-day review. Its family tree reaches back 3 generations to 1992. 207 later devices descend from it.
- Decided
- Jun 24, 1999
- Review
- 21 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922901 (1992). 9 ancestors in all. 207 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 2 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 1 generation backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- This deviceK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- Descendant · cites it directly · 153 of its ownK072779 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- Descendant · 2 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · cites it directly · 79 of its ownK053161 SirolaserSirona Dental Systems GmbH · 2006
- Descendant · 2 generations on · 71 of its ownK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
Showing 5 of 207 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 207 · See all- K072779Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008 · cites it directly153descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 2 generations on112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
- K053161SirolaserSirona Dental Systems GmbH · 2006 · cites it directly79descendants
- K062258Genesis Diode LaserIvoclar Vivadent, Inc. · 2007 · 2 generations on71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −2 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −1 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| 0 (this device) | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| +1 | K072779 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| +2 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +1 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| +2 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 11 | 0 |
| 2009 | 5 | 0 |
| 2010 | 10 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 9 | 0 |
| 2018 | 11 | 0 |
| 2019 | 11 | 0 |
| 2020 | 14 | 0 |
| 2021 | 10 | 0 |
| 2022 | 21 | 0 |
| 2023 | 12 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 16 | 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? (2)
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 |
|---|---|---|---|
| * | K983058 | Ceralas D Laser System, Model # Ceralas D15Summary page 1…aser Intended Use The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System that has already been cleared by FDA (K983058) for use in the following dental indications: draining fistulas, coagulation and decontamination of extraction sites, frenectomy,… | 1998 |
| * | — | Premier Laser System Pegasus Nd:YAG Laser Named without a submission number |
What descends from it? (207)
See all 2075 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K072779 (Biolitec, Inc., 2008) has gone furthest, with 153 descendants of its own.
- 5 other devices also cite its predicate K983058.
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
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/K991891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991891: Ceralas Diode Laser System, Model Ceralas D15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991891
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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