510(k) · Cleared
ClearedCeralas 980NM Diode Laser Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolitec Medical Devices, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 6, 2011 after a 25-day review. The FDA summary names its predicate without a number. 25 later devices descend from it.
- Decided
- Sep 6, 2011
- Review
- 25 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 2 citing it directly.
- This deviceK112324 Ceralas 980NM Diode Laser FamilyBiolitec Medical Devices, Inc. · 2011
- Descendant · cites it directly · 17 of its ownK152722 neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd. · 2015
- Descendant · 2 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · cites it directly · 6 of its ownK112013 Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK240747 Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 4 of its ownK120231 Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc. · 2012
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd. · 2015 · cites it directly17descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 2 generations on11descendants
- K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc. · 2012 · cites it directly6descendants
- K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd. · 2024 · 2 generations on4descendants
- K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc. · 2012 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112324 | Ceralas 980NM Diode Laser Family | Biolitec Medical Devices, Inc. | 2011 | — |
| +1 | K152722 | neoV980 & neoV1470 Diode Lasers | G.N.S Neolaser, Ltd. | 2015 | — |
| +2 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +1 | K112013 | Evolve (R) HPD 980/1470NM Multiwavelength Diode Laser | Biolitec, Inc. | 2012 | — |
| +2 | K240747 | Medical Diode Laser (M2-GK) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
| +2 | K120231 | Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual) | Biolitec Medical Devices, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2015 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | — | Ceralas 980nm Diode Laser Family Named without a submission number |
What descends from it? (25)
See all 252 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, K152722 (G.N.S Neolaser, Ltd., 2015) has gone furthest, with 17 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. 2011, 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?
The Ceralas Fiber-Coupled 980nm Diode Laser family (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs…
Read the full statement (104 words)
The Ceralas Fiber-Coupled 980nm Diode Laser family (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.
Indications include: General Surgery, Urology, Gynecology, Gastroenterology, Otolaryngology, Plastic Surgery, Dermatology, Podiatry, Neurosurgery! Peripheral, Pulmonary Surgery, Arthroscopy, Cardiothoracic Surgery, Laser Assisted Lipolysis, Ophthalmology, Dental Applications, Endovenous Occlusion of the Greater Saphenous Vein.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112324: Ceralas 980NM Diode Laser Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112324
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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