510(k) Report

510(k) · Cleared

Cleared

150W Ceralas D 980NM Diode Laser

K072106510(k) SpecialCleared Aug 30, 200730-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biolitec, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Aug 30, 2007 as substantially equivalent to K050824 (Biolitec, Inc., 2005) and 3 other predicates after a 30-day review. Its family tree reaches back 15 generations to 1995. 229 later devices descend from it.

Decided
Aug 30, 2007
Review
30 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
4

Its longest line of descent runs back 15 generations to K943450 (1995). 166 ancestors in all, the oldest K800617 (1980). 229 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 4 other ancestors2004: 6 other ancestors2003: 12 other ancestors2002: 17 other ancestors2001: 12 other ancestors2000: 13 other ancestors1995: 13 other ancestors1990: 2 other ancestors1998: 9 other ancestors1997: 18 other ancestors1999: 6 other ancestors1996: 14 other ancestors1993: 6 other ancestors1994: 9 other ancestors1989: 1 other ancestor1985: 1 other ancestor1980: 1 other ancestor1992: 3 other ancestors1991: 3 other ancestors2009: 5 descendants cleared2008: 3 descendants cleared2010: 6 descendants cleared2022: 24 descendants cleared2020: 16 descendants cleared2021: 10 descendants cleared2011: 4 descendants cleared2012: 5 descendants cleared2013: 9 descendants cleared2015: 10 descendants cleared2016: 11 descendants cleared2024: 24 descendants cleared2014: 10 descendants cleared2026: 19 descendants cleared2018: 13 descendants cleared2019: 11 descendants cleared2017: 8 descendants cleared2023: 12 descendants cleared2025: 29 descendants clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006K071295 · 100W Ceralas D 980NM Diode Laser · Biolitec, Inc. · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 16 other ancestors3 generations back: 14 other ancestors4 generations back: 28 other ancestors5 generations back: 33 other ancestors6 generations back: 23 other ancestors7 generations back: 30 other ancestors8 generations back: 3 other ancestors9 generations back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 16 descendants3 generations forward: 38 descendants4 generations forward: 47 descendants5 generations forward: 44 descendants6 generations forward: 46 descendants7 generations forward: 26 descendants8 generations forward: 5 descendants9 generations forward: 1 descendant K071295 · 100W Ceralas D 980NM Diode Laser · Biolitec, Inc. · 2007K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−15−10−50+5
  1. Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 11 generations between
  3. 3 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  4. 2 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  5. 1 generation backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  6. This deviceK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  7. Descendant · cites it directly · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
  8. Descendant · cites it directly · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
  9. Descendant · cites it directly · 121 of its ownK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
  10. Descendant · cites it directly · 112 of its ownK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
  11. Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Show all 15 generations
  1. Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 3 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  14. 2 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  15. 1 generation backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  16. This deviceK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007

Showing 5 of 229 descendants. See all descendants

Descendants cleared per year

2008: 32009: 52010: 62011: 42012: 52013: 92014: 102015: 102016: 112017: 82018: 132019: 112020: 162021: 102022: 242023: 122024: 242025: 292026: 19
2008high 29 (2025) · low 3 (2008)2026

Most influential descendants

Showing 5 of 229 · See all
  • K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · cites it directly192descendants
  • K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · cites it directly177descendants
  • K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009 · cites it directly121descendants
  • K082230Vectra Plus Laser System and AccessoriesXintec Corporation · 2010 · cites it directly112descendants
  • K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−14K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−13K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−12K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−11K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−10K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−9K000944Thermage Thermacool SystemThermage, Inc.2000—
−8K013034Modification to: Thermacool IiaThermage, Inc.2001—
−7K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−6K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−5K030142Thermacool TC SystemThermage, Inc.2003—
−4K031671Polaris WRSyneron Medical, Ltd.2003—
−3K041959Polaris DS/CometSyneron Medical, Ltd.2004—
−2K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
−1K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
0 (this device)K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
+1K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008—
+1K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009—
+1K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009—
+1K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010—
+2K101916Joule Multi-Platform SystemSciton, Inc2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
198910
199020
199130
199230
199360
199490
1995130
1996140
1997180
199890
199960
2000130
2001120
2002170
2003120
200460
200540
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200830
200950
201060
201140
201250
201390
2014100
2015100
2016110
201780
2018130
2019110
2020160
2021100
2022240
2023120
2024240
2025290
2026190
FIG. 1 — Lineage of K072106, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K050824100W Ceralas D 980 Laser System, Model D100
Summary page 1
…mmon or Usual Name Diode Laser Classification Name Laser, Surgical Diode Laser System Predicate Devices Biolitec's 100W Ceralas D 980nm Diode Laser ((K050824, K071295) INTERmedic Diode Laser Family 890nm and 980nm (K053540) Xintec Vectra Diode Laser (K060114)…
Biolitec, Inc.2005—
*K071295100W Ceralas D 980NM Diode Laser
Summary page 1
…sual Name Diode Laser Classification Name Laser, Surgical Diode Laser System Predicate Devices Biolitec's 100W Ceralas D 980nm Diode Laser ((K050824, K071295) INTERmedic Diode Laser Family 890nm and 980nm (K053540) Xintec Vectra Diode Laser (K060114) Intended…
Biolitec, Inc.2007—
*K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…
Summary page 1
…Surgical Diode Laser System Predicate Devices Biolitec's 100W Ceralas D 980nm Diode Laser ((K050824, K071295) INTERmedic Diode Laser Family 890nm and 980nm (K053540) Xintec Vectra Diode Laser (K060114) Intended Use / Indications for Use The device is intended for de…
Intermedic Arfran, SA2006—
*K060114Vectra Laser System
Summary page 1
…ices Biolitec's 100W Ceralas D 980nm Diode Laser ((K050824, K071295) INTERmedic Diode Laser Family 890nm and 980nm (K053540) Xintec Vectra Diode Laser (K060114) Intended Use / Indications for Use The device is intended for delivery of laser light to soft tissue in th…
Xintec Corporation, Dba,2006—

Also cleared against K050824: 8 other devices →

What descends from it? (229)

See all 229

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192
K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177
K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121
K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112
K082938EzlaseBiolase Technology, Inc.200850
K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822

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 166 ancestors have a recall of any class.
  • Of its descendants, K083613 (Quanta System Spa, 2008) has gone furthest, with 192 descendants of its own.
  • 8 other devices also cite its predicate K050824.

How does its category compare?

All GEX devices

GEX 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

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

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 150W 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 150W 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 otteleangectasia 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.

Cite this page

510(k) Report. “K072106: 150W 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/K072106

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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