510(k) · Cleared
ClearedCeralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode Laser Family, Ceralas HPD/ 980NM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolitec, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 15, 2010 as substantially equivalent to K072682 (Biolitec, Inc., 2008) and 4 other predicates after a 184-day review. Its family tree reaches back 17 generations to 1995. 54 later devices descend from it.
- Decided
- Sep 15, 2010
- Review
- 184 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K943450 (1995). 329 ancestors in all, the oldest K771218 (1978). 54 later devices descend from it, 3 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- This deviceK100726 Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM…Biolitec, Inc. · 2010
- Descendant · cites it directly · 46 of its ownK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- Descendant · cites it directly · 26 of its ownK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
- Descendant · 2 generations on · 24 of its ownK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
- Descendant · 2 generations on · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- Descendant · 2 generations on · 18 of its ownK112253 Ceralas 147NM Diode Laser SystemBiolitec, Inc. · 2011
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 4 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- This deviceK100726 Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM…Biolitec, Inc. · 2010
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc. · 2010 · cites it directly46descendants
- K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011 · cites it directly26descendants
- K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012 · 2 generations on24descendants
- K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · 2 generations on23descendants
- K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc. · 2011 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −4 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −3 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −2 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −1 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| 0 (this device) | K100726 | Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM… | Biolitec, Inc. | 2010 | — |
| +1 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| +1 | K110080 | Radial-Emitting Shaped Fiber Optic Delivery System | Biolitec, Inc. | 2011 | — |
| +2 | K120810 | Fiberoptic Laser Delivery System | Fiberoptic Fabrications, Inc. | 2012 | — |
| +2 | K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers… | Med-Fibers, Inc. | 2013 | — |
| +2 | K112253 | Ceralas 147NM Diode Laser System | Biolitec, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 18 | 0 |
| 1995 | 17 | 0 |
| 1996 | 22 | 0 |
| 1997 | 26 | 0 |
| 1998 | 22 | 0 |
| 1999 | 17 | 0 |
| 2000 | 27 | 0 |
| 2001 | 29 | 0 |
| 2002 | 33 | 0 |
| 2003 | 28 | 0 |
| 2004 | 18 | 0 |
| 2005 | 11 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 9 | 0 |
| 2025 | 11 | 0 |
| 2026 | 3 | 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? (6)
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 |
|---|---|---|---|
| * | K072682 | 50W Ceralas D 1950NM Diode LaserSummary page 1…General Surgery Devices Branch has classified Diode Lasers as Class 11devices pursuant to 21 C.F.R. § 878.4810 V. Predicate Devices: Ceralas SOW Ceralas D1950 (K072682) Ceralas G15 532 Frequency Doubled Nd:Yag (K002296) Quanta System Polysurge Diode Laser Family (K<083613) Quanta System Diode Med… | 2008 |
| * | K002296 | Ceralas G15 532NM Frequency Doubled ND:Yag Laser, Model G1-G15Summary page 1…Lasers as Class 11devices pursuant to 21 C.F.R. § 878.4810 V. Predicate Devices: Ceralas SOW Ceralas D1950 (K072682) Ceralas G15 532 Frequency Doubled Nd:Yag (K002296) Quanta System Polysurge Diode Laser Family (K<083613) Quanta System Diode Medical Laser Family (K<072034) INTERmedic Diode Laser… | 2000 |
| * | K083613 | Quanta System Polysurge Diode Laser FamilySummary page 1…4810 V. Predicate Devices: Ceralas SOW Ceralas D1950 (K072682) Ceralas G15 532 Frequency Doubled Nd:Yag (K002296) Quanta System Polysurge Diode Laser Family (K<083613) Quanta System Diode Medical Laser Family (K<072034) INTERmedic Diode Laser family 810nm & 9S0nm (1<053540) v… | 2008 |
| * | K072034 | Diode Medical Laser Family, Models 4, 6, 30Summary page 1…alas D1950 (K072682) Ceralas G15 532 Frequency Doubled Nd:Yag (K002296) Quanta System Polysurge Diode Laser Family (K<083613) Quanta System Diode Medical Laser Family (K<072034) INTERmedic Diode Laser family 810nm & 9S0nm (1<053540) vi. Intended Use/ indications for Use… | 2007 |
| * | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Summary page 1…Nd:Yag (K002296) Quanta System Polysurge Diode Laser Family (K<083613) Quanta System Diode Medical Laser Family (K<072034) INTERmedic Diode Laser family 810nm & 9S0nm (1<053540) vi. Intended Use/ indications for Use The Ceralas Fiber-Coupled… | 2006 |
| * | — | Quanta System Model 30 (808nm & 940nm) laser family Named without a submission number |
What descends from it? (54)
See all 543 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 15 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 16 of the 329 ancestors have a recall of any class.
- Of its descendants, K102755 (Biolitec, Inc., 2010) has gone furthest, with 46 descendants of its own.
- 2 other devices also cite its predicate K072682.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Diode Laser family 9S0nm (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cuffing, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endloscopic 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.
Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100726 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100726: Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode Laser Family, Ceralas HPD/ 980NM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100726
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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