510(k) Report

510(k) · Cleared

Cleared

180W Cerelas D 980NM Diode Laser, Model D180

K083682510(k) SpecialCleared Jan 9, 200929-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 Jan 9, 2009 as substantially equivalent to K072106 (Biolitec, Inc., 2007) after a 29-day review. Its family tree reaches back 16 generations to 1995. 121 later devices descend from it.

Decided
Jan 9, 2009
Review
29 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
1

Its longest line of descent runs back 16 generations to K943450 (1995). 167 ancestors in all, the oldest K800617 (1980). 121 later devices descend from it, 3 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 ancestors2010: 1 descendant cleared2012: 3 descendants cleared2009: 1 descendant cleared2011: 1 descendant cleared2014: 3 descendants cleared2018: 8 descendants cleared2022: 18 descendants cleared2020: 12 descendants cleared2015: 6 descendants cleared2017: 4 descendants cleared2025: 15 descendants cleared2026: 12 descendants cleared2019: 6 descendants cleared2024: 13 descendants cleared2023: 9 descendants cleared2021: 8 descendants cleared2016: 1 descendant 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 · 2006×2: 2 generations cleared close together, K071295 (2007), K072106 (2007) 19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 16 other ancestors4 generations back: 14 other ancestors5 generations back: 28 other ancestors6 generations back: 33 other ancestors7 generations back: 23 other ancestors8 generations back: 30 other ancestors9 generations back: 3 other ancestors10 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 7 descendants4 generations forward: 23 descendants5 generations forward: 30 descendants6 generations forward: 34 descendants7 generations forward: 18 descendants8 generations forward: 3 descendants K072106 · 150W Ceralas D 980NM Diode Laser · Biolitec, Inc. · 2007K071295 · 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 · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 12 generations between
  3. 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  4. 2 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  5. 1 generation backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  6. This deviceK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
  7. Descendant · cites it directly · 112 of its ownK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
  8. Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
  9. Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
  10. Descendant · 4 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
  11. Descendant · 3 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
Show all 16 generations
  1. Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 4 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  14. 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  15. 2 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  16. 1 generation backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  17. This deviceK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009

Showing 5 of 121 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 12012: 32014: 32015: 62016: 12017: 42018: 82019: 62020: 122021: 82022: 182023: 92024: 132025: 152026: 12
2009high 18 (2022) · low 0 (2013)2026

Most influential descendants

Showing 5 of 121 · See all
  • K082230Vectra Plus Laser System and AccessoriesXintec Corporation · 2010 · cites it directly112descendants
  • K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
  • K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
  • K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 4 generations on62descendants
  • K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 3 generations on57descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−15K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−14K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−13K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−12K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−11K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−10K000944Thermage Thermacool SystemThermage, Inc.2000—
−9K013034Modification to: Thermacool IiaThermage, Inc.2001—
−8K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−7K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−6K030142Thermacool TC SystemThermage, Inc.2003—
−5K031671Polaris WRSyneron Medical, Ltd.2003—
−4K041959Polaris DS/CometSyneron Medical, Ltd.2004—
−3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
−2K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−1K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
0 (this device)K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009—
+1K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010—
+2K101916Joule Multi-Platform SystemSciton, Inc2011—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.2014—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.2015—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.2014—

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
200910
201010
201110
201230
201430
201560
201610
201740
201880
201960
2020120
202180
2022180
202390
2024130
2025150
2026120
FIG. 1 — Lineage of K083682, 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K072106150W Ceralas D 980NM Diode Laser
Summary page 1
…e Diode Laser Classification Name Laser, Surgical Diode Laser System Predicate Devices Biolitec's 150W Ceralas D 980nm Diode Laser (K072106) Intended Use / Indications for Use The device is intended for delivery oflaser light to soft tissue in the contact…
Biolitec, Inc.2007—

Also cleared against K072106: 5 other devices →

What descends from it? (121)

See all 121

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

NumberDeviceApplicantDecidedDescendants
K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112
K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126
K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090

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 14 years and passes through 5 companies; a new generation was cleared every 9 months on median.
  • 7 of the 167 ancestors have a recall of any class.
  • Of its descendants, K082230 (Xintec Corporation, 2010) has gone furthest, with 112 descendants of its own.
  • 5 other devices also cite its predicate K072106.

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. 2009, 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 180W Ceralas D 980 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 (664 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 180W Ceralas D 980 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 as stated in the FDA summary.

Cite this page

510(k) Report. “K083682: 180W Cerelas D 980NM Diode Laser, Model D180.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083682

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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