510(k) · Cleared
ClearedCeralas D 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 Oct 21, 1998 as substantially equivalent to K951775 (Ceram Optec, Inc., 1995) and 6 other predicates after a 50-day review. Its family tree reaches back 2 generations to 1992. 208 later devices descend from it.
- Decided
- Oct 21, 1998
- Review
- 50 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K922901 (1992). 8 ancestors in all. 208 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 1 generation backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- This deviceK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- Descendant · cites it directly · 207 of its ownK991891 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
Showing 5 of 208 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 208 · See all- K991891Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999 · cites it directly207descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −1 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| 0 (this device) | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 1999 | 1 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K951775 | Ceralas Diode Laser System (Model Ceralas D50)Summary page 1…rican Dental Technologies Pulsemaster® 1000 Nd:YAG Laser Intended Use There have been no significant changes to the Ceralas D Laser System since is was cleared by FDA (K951775, K964497). The Ceralas D Laser System has been cleared as a surgical instrument intended for incision, excision, hemostasis, coag… | 1995 |
| * | K964497 | Ceralas Diode Laser System (Ceralas D15)Summary page 1…tal Technologies Pulsemaster® 1000 Nd:YAG Laser Intended Use There have been no significant changes to the Ceralas D Laser System since is was cleared by FDA (K951775, K964497). The Ceralas D Laser System has been cleared as a surgical instrument intended for incision, excision, hemostasis, coagulation,… | 1997 |
| * | K954316 | Aurora Surgical Diode Laser System W/AccessoriesSummary page 2…Ceralas D Laser System is substantially equivalent to the previously cleared Ceralas D Laser System (K951775, K964497), Premier Laser Systems’ Aurora Diode Dental Laser (K954316, K974586), American Dental Technologies’ Pulsemaster® 1000 ST Dental Diode Laser System (K972325), and American Dental Technologi… | 1995 |
| * | K974586 | Aurora Diode Laser SystemSummary page 2…Laser System is substantially equivalent to the previously cleared Ceralas D Laser System (K951775, K964497), Premier Laser Systems’ Aurora Diode Dental Laser (K954316, K974586), American Dental Technologies’ Pulsemaster® 1000 ST Dental Diode Laser System (K972325), and American Dental Technologies’ Pulse… | 1998 |
| * | K972325 | Pulsemaster 1000 ST Dental Laser SystemSummary page 2…em (K951775, K964497), Premier Laser Systems’ Aurora Diode Dental Laser (K954316, K974586), American Dental Technologies’ Pulsemaster® 1000 ST Dental Diode Laser System (K972325), and American Dental Technologies’ Pulsemaster® 1000 Nd:YAG Laser (K961269, K961136). Technological Characteristics and Substan… | 1997 |
| * | K961269 | PulsemasterSummary page 2…4316, K974586), American Dental Technologies’ Pulsemaster® 1000 ST Dental Diode Laser System (K972325), and American Dental Technologies’ Pulsemaster® 1000 Nd:YAG Laser (K961269, K961136). Technological Characteristics and Substantial Equivalence As stated above, there have been no significant changes to… | 1997 |
| * | K961136 | PulsemasterSummary page 2…4586), American Dental Technologies’ Pulsemaster® 1000 ST Dental Diode Laser System (K972325), and American Dental Technologies’ Pulsemaster® 1000 Nd:YAG Laser (K961269, K961136). Technological Characteristics and Substantial Equivalence As stated above, there have been no significant changes to the Cera… | 1996 |
| † | K942182 | Megabeam Dental Fiber | 1994 |
What descends from it? (208)
See all 2086 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 6 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K991891 (Ceram Optec, Inc., 1999) has gone furthest, with 207 descendants of its own.
- 3 other devices also cite its predicate K951775.
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?
The Ceralas D Laser System is indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining…
Read the full statement (99 words)
The Ceralas D Laser System is indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; leukoplakia; removal of hyperplastic tissues; treatment of aphthous ulcers; and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
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/K983058 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983058: Ceralas D 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/K983058
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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