510(k) · Cleared
Cleared100W Ceralas D 980NM Diode Laser
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 May 16, 2007 as substantially equivalent to K050824 (Biolitec, Inc., 2005) and 2 other predicates after an 8-day review. Its family tree reaches back 14 generations to 1995. 230 later devices descend from it.
- Decided
- May 16, 2007
- Review
- 8 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K943450 (1995). 162 ancestors in all, the oldest K800617 (1980). 230 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 1 generation backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- This deviceK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- Descendant · cites it directly · 229 of its ownK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- Descendant · 2 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 2 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
- Descendant · 2 generations on · 121 of its ownK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- Descendant · cites it directly · 112 of its ownK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 1 generation backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- This deviceK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
Showing 5 of 230 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 230 · See all- K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · cites it directly229descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 2 generations on192descendants
- K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 2 generations on177descendants
- K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009 · 2 generations on121descendants
- K082230Vectra Plus Laser System and AccessoriesXintec Corporation · 2010 · cites it directly112descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −2 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −1 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| 0 (this device) | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| +1 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| +2 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +2 | K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | Biolitec, Inc. | 2009 | — |
| +2 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| +1 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 12 | 0 |
| 1996 | 14 | 0 |
| 1997 | 18 | 0 |
| 1998 | 9 | 0 |
| 1999 | 6 | 0 |
| 2000 | 13 | 0 |
| 2001 | 12 | 0 |
| 2002 | 17 | 0 |
| 2003 | 12 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 9 | 0 |
| 2014 | 10 | 0 |
| 2015 | 10 | 0 |
| 2016 | 11 | 0 |
| 2017 | 8 | 0 |
| 2018 | 13 | 0 |
| 2019 | 11 | 0 |
| 2020 | 16 | 0 |
| 2021 | 10 | 0 |
| 2022 | 24 | 0 |
| 2023 | 12 | 0 |
| 2024 | 24 | 0 |
| 2025 | 29 | 0 |
| 2026 | 19 | 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? (3)
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 |
|---|---|---|---|
| * | K050824 | 100W Ceralas D 980 Laser System, Model D100Summary page 1…ommon or Usual Name Diode Laser Classification Name Laser, Surgical Diode Laser System Predicate Devices Biolitec's 100W Ceralas D 980nm Diode Laser (K050824) INTERmedic Diode Laser Family 890nm and 980nm (K053540) Laserscope Lyra GTM Series Surgical Laser System (K010284)… | 2005 |
| * | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Summary page 1…Laser, Surgical Diode Laser System Predicate Devices Biolitec's 100W Ceralas D 980nm Diode Laser (K050824) INTERmedic Diode Laser Family 890nm and 980nm (K053540) Laserscope Lyra GTM Series Surgical Laser System (K010284) Intended Use / Indications for Use The device is intende… | 2006 |
| * | K010284 | Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)Summary page 1…olitec's 100W Ceralas D 980nm Diode Laser (K050824) INTERmedic Diode Laser Family 890nm and 980nm (K053540) Laserscope Lyra GTM Series Surgical Laser System (K010284) Intended Use / Indications for Use The device is intended for delivery of laser light to soft tissue in the contact… | 2001 |
What descends from it? (230)
See all 2303 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 12 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 7 of the 162 ancestors have a recall of any class.
- Of its descendants, K072106 (Biolitec, Inc., 2007) has gone furthest, with 229 descendants of its own.
- 8 other devices also cite its predicate K050824.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 100W Ceralas D980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology…
Read the full statement (662 words)
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 100W Ceralas D980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent'areas including soft tissue in the oral cavity. Examples include:
Removal of benign lesions from the ear, nose and throat
Excision and vaporization of vocal cord nodules and polyps
Incision and excision of carcinoma in situ
Ablation and vaporization of hyperkeratosis
Excision of carcinoma of the larynx
Laryngeal papillomectomy
Excision and vaporization of herpes simplex I and II
Neck dissection
Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:
Menisectomy
Synovectomy
Chondromalacia
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:
Hemostasis of upper and lower GI bleeding
Excision and vaporization of colorectal carcinoma
Excision of polyps
General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:
Matrixectomy
Excision of neuromas
Excision of periungual and subungual warts
Excision of plantar warts
Excision of keloids
Liver resection
Excision of cutaneous lesions
Hemorrhoidectomy
Appendectomy
Debridement of decubitus ulcers
Hepatobiliary tumors
Mastectomy
Dermabrasion
Vaporization and hemostasis of capillary hemangioma
Excision, vaporization and hemostasis of abdominal tumors
Excision, vaporization and hemostasis of rectal pathology
Pilonidal cystectomy
Herniorapphy
Adhesiolysis
Parathyroidectomy
Laparoscopic cholecystectomy
Thyroidectomy
Resection of organs
Debridement of wounds
Photocoagulation of teleangectasia of the legs and face
Photocoagulation of vascular lesions of the face and extremities
Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Treatment of reticular veins and branch varicosities
Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:
Vaporization of urethral tumors
Release of urethral stricture
Removal of bladder neck obstruction
Excision and vaporization of condyloma
Lesions of external genitalia
Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
Endometrial ablation
Excision or vaporization of condylomata acuminate
Vaporization of cervical intraepithelial neoplasia
Cervical conization
Menorrhagia
Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas
Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.
Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:
Tracheobronchial malignancy or stricture
Benign and malignant pulmonary obstruction
Endoscopic pulmonary applications
Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): 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, vestibuloplasy, 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), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
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/K071295 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071295: 100W Ceralas D 980NM Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071295
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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