510(k) · Cleared
ClearedCeralas D10 810NM Laser, Model Ceralas D10-60
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 Aug 4, 2000 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Aug 4, 2000
- Review
- 36 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK001975 Ceralas D10 810NM Laser, Model Ceralas D10-60Ceram Optec, Inc. · 2000
- Descendant · cites it directly · 7 of its ownK082721 Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc. · 2008 · Recalled
- Descendant · cites it directly · 6 of its ownK013201 Cardiofocus Diode Laser System, Models 60R, 60NR, 30NRCardiofocus, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK040744 Atrilaze Soft Tissue Ablation SystemMedical Cv, Inc. · 2004
- Descendant · 2 generations on · 4 of its ownK052495 Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005
- Descendant · 2 generations on · 3 of its ownK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc. · 2008 · cites it directly7descendants
- K013201Cardiofocus Diode Laser System, Models 60R, 60NR, 30NRCardiofocus, Inc. · 2002 · cites it directly6descendants
- K040744Atrilaze Soft Tissue Ablation SystemMedical Cv, Inc. · 2004 · cites it directly5descendants
- K052495Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005 · 2 generations on4descendants
- K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001975 | Ceralas D10 810NM Laser, Model Ceralas D10-60 | Ceram Optec, Inc. | 2000 | — |
| +1 | K082721 | Laserpro 810, 940 and 980 Diode Laser Systems | Photo Medex, Inc. | 2008 | 1 |
| +1 | K013201 | Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR | Cardiofocus, Inc. | 2002 | — |
| +1 | K040744 | Atrilaze Soft Tissue Ablation System | Medical Cv, Inc. | 2004 | — |
| +2 | K052495 | Atrilaze Malleable Ablation Probe | Medical Cv, Inc. | 2005 | — |
| +2 | K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 153 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?
- Of its descendants, K082721 (Photo Medex, Inc., 2008) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K001975 · printed Nov 4, 2026
Cite this page
510(k) Report. “K001975: Ceralas D10 810NM Laser, Model Ceralas D10-60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001975
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026