510(k) Report

510(k) · Cleared

Cleared

Ceralas E 980NM Diode Laser, Models E15/980 and E30/980

K082263510(k) SpecialCleared Oct 24, 200877-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 Oct 24, 2008 as substantially equivalent to K032863 (Biolitec, Inc., 2004) and 2 other predicates after a 77-day review. Its family tree reaches back 16 generations to 1995. 1 later device descends from it.

Decided
Oct 24, 2008
Review
77 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
3

Its longest line of descent runs back 16 generations to K943450 (1995). 185 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2004: 9 other ancestors2006: 1 other ancestor2000: 14 other ancestors1999: 8 other ancestors1998: 11 other ancestors1997: 21 other ancestors2007: 1 other ancestor2002: 17 other ancestors1996: 16 other ancestors1995: 13 other ancestors2005: 5 other ancestors2003: 13 other ancestors2001: 13 other ancestors1992: 4 other ancestors1993: 6 other ancestors1985: 1 other ancestor1980: 1 other ancestor1994: 9 other ancestors1990: 1 other ancestor1989: 1 other ancestor1991: 3 other ancestors2010: 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 · 2006K072034 · Diode Medical Laser Family, Models 4, 6, 30 · Quanta System Spa · 2007K081015 · Ceralas D 980NM Diode Laser, Models D15 and D25 · Biolitec, Inc. · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 10 other ancestors4 generations back: 21 other ancestors5 generations back: 16 other ancestors6 generations back: 30 other ancestors7 generations back: 31 other ancestors8 generations back: 21 other ancestors9 generations back: 27 other ancestors10 generations back: 3 other ancestors11 generations back: 2 other ancestors 1 generation forward: 1 descendant K081015 · Ceralas D 980NM Diode Laser, Models D15 and D25 · Biolitec, Inc. · 2008K072034 · Diode Medical Laser Family, Models 4, 6, 30 · Quanta System Spa · 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
  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 backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
  5. 1 generation backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
  6. This deviceK082263 Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc. · 2008
  7. Descendant · cites it directly · 0 of its ownK093087 BWF-5 Medical Laser SeriesLitecure, LLC · 2010
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 backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
  16. 1 generation backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
  17. This deviceK082263 Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K093087BWF-5 Medical Laser SeriesLitecure, LLC · 2010 · cites it directly0descendants
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—
−2K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007—
−1K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.2008—
0 (this device)K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.2008—
+1K093087BWF-5 Medical Laser SeriesLitecure, LLC2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
198910
199010
199130
199240
199360
199490
1995130
1996160
1997210
1998110
199980
2000140
2001130
2002170
2003130
200490
200550
200610
200710
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K082263, 1995–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K032863Ceralas D 980 Diode Laser System, Models D15, D25, D50
Summary page 1
…gical Diode Laser System CFR Provision and Product Code 21 C.F.R. 878.4810, GEX Predicate Devices Biolitec Ceralas D 980 Diode Laser (Models DI5, D25) (K032863, K072779, K081015) Purpose of the Special 510(k) notice. The Ceralas El 5/980, E30/980 is a modification to Ceralas D 98…
Biolitec, Inc.2004—
*K072779Ceralas D 980NM Diode Laser, Models D15 and D25
Summary page 1
…de Laser System CFR Provision and Product Code 21 C.F.R. 878.4810, GEX Predicate Devices Biolitec Ceralas D 980 Diode Laser (Models DI5, D25) (K032863, K072779, K081015) Purpose of the Special 510(k) notice. The Ceralas El 5/980, E30/980 is a modification to Ceralas D 980. === P…
Biolitec, Inc.2008—
*K081015Ceralas D 980NM Diode Laser, Models D15 and D25
Summary page 1
…System CFR Provision and Product Code 21 C.F.R. 878.4810, GEX Predicate Devices Biolitec Ceralas D 980 Diode Laser (Models DI5, D25) (K032863, K072779, K081015) Purpose of the Special 510(k) notice. The Ceralas El 5/980, E30/980 is a modification to Ceralas D 980.…
Biolitec, Inc.2008—

Also cleared against K032863: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093087BWF-5 Medical Laser SeriesLitecure, LLC20100

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 13 years and passes through 6 companies; a new generation was cleared every 10 months on median.
  • 7 of the 185 ancestors have a recall of any class.
  • Of its descendants, K093087 (Litecure, LLC, 2010) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K032863.

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. 2008, 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 Ceralas E15/980, E30/980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas E15/980, E30/980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general…

Read the full statement (655 words)

The Ceralas E15/980, E30/980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas E15/980, E30/980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, and ophthalmology. This Ceralas E15/980, E30/980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue) and laser assisted lipolysis.

Specific Indications for Use

Ear, Nose and Throat and Oral Surgery.

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

Tonsillectomy

Thyroidectomy

Vocal cord polypectomy

Hemiglossectomy

Tracheal stenosis

Oral cavity lesions

Dental Applications.

Intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include:

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

Vestibuloplasty

Excision of lesions

Exposure of unerupted/partially erupted teeth

Leukoplakia

Removal of hyperplastic tissues

Treatment of aphthous ulcers

Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)

Pulpotomy

Pulpotomy as an adjunct to root canal therapy

Light activation of bleaching materials for teeth whitening

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

Hemiorapphy

Adhesiolysis

Parathyroidectomy

Laparoscopic cholecystectomy

Thyroidectomy

Resection of organs

Debridement of wounds

Phototcoagulation 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

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

Gynecology:

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

Endometrial ablation

Excision or vaporization of condylomata acuminata

Vaporization of cervical intraepithelial neoplasia

Cervical conization

Menorrhagia

Neurosurgery:

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Example includes:

Hemostasis in conjunction with menigiomas

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

CardiothoracicSurgery:

Incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, including cardiac tissues.

Laser Assisted Lipolysis

Ophthalmology:

The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology. Examples include:

Open Dacryocystorhinostomy

Endonasal Dacryocystorhinostomy

Blepharoplasty

Oculoplastics

Tumor excision, and biopsy

Eyelid reconstruction

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. “K082263: Ceralas E 980NM Diode Laser, Models E15/980 and E30/980.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082263

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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