510(k) · Cleared
ClearedCeralas E 980NM Diode Laser, Models E15/980 and E30/980
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 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.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 1 generation backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- This deviceK082263 Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK093087 BWF-5 Medical Laser SeriesLitecure, LLC · 2010
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 1 generation backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −3 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −2 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −1 | K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| 0 (this device) | K082263 | Ceralas E 980NM Diode Laser, Models E15/980 and E30/980 | Biolitec, Inc. | 2008 | — |
| +1 | K093087 | BWF-5 Medical Laser Series | Litecure, LLC | 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 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 13 | 0 |
| 1996 | 16 | 0 |
| 1997 | 21 | 0 |
| 1998 | 11 | 0 |
| 1999 | 8 | 0 |
| 2000 | 14 | 0 |
| 2001 | 13 | 0 |
| 2002 | 17 | 0 |
| 2003 | 13 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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 |
|---|---|---|---|
| * | K032863 | Ceralas D 980 Diode Laser System, Models D15, D25, D50Summary 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… | 2004 |
| * | K072779 | Ceralas D 980NM Diode Laser, Models D15 and D25Summary 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… | 2008 |
| * | K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25Summary 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.… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093087 | BWF-5 Medical Laser Series | 2010 | 0 |
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 devicesGEX 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
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 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.
https://510kreport.com/device/K082263 · printed Nov 6, 2026
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