510(k) · Cleared
ClearedCeralas D 980NM Diode Laser, Models D15 and D25
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 Jul 8, 2008 as substantially equivalent to K072779 (Biolitec, Inc., 2008) and 1 other predicate after a 90-day review. Its family tree reaches back 15 generations to 1995. 34 later devices descend from it.
- Decided
- Jul 8, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K943450 (1995). 184 ancestors in all, the oldest K800617 (1980). 34 later devices descend from it, 6 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 2 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 1 generation backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- This deviceK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- Descendant · cites it directly · 23 of its ownK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- Descendant · 2 generations on · 22 of its ownK111689 StlaseDental Photonics, Inc. · 2012
- Descendant · 3 generations on · 16 of its ownK163128 Epic ProBiolase, Inc. · 2017
- Descendant · 4 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · cites it directly · 5 of its ownK212734 Diode laser therapy deviceTriangel Rsd Limited · 2023
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 2 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 1 generation backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- This deviceK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K094049Stlase Diode LaserDental Photonics, Inc. · 2010 · cites it directly23descendants
- K111689StlaseDental Photonics, Inc. · 2012 · 2 generations on22descendants
- K163128Epic ProBiolase, Inc. · 2017 · 3 generations on16descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 4 generations on11descendants
- K212734Diode laser therapy deviceTriangel Rsd Limited · 2023 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −2 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −1 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| 0 (this device) | K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| +1 | K094049 | Stlase Diode Laser | Dental Photonics, Inc. | 2010 | — |
| +2 | K111689 | Stlase | Dental Photonics, Inc. | 2012 | — |
| +3 | K163128 | Epic Pro | Biolase, Inc. | 2017 | — |
| +4 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +1 | K212734 | Diode laser therapy device | Triangel Rsd Limited | 2023 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K072779 | Ceralas D 980NM Diode Laser, Models D15 and D25Summary page 1…878.48 10 - Laser, Surgical Diode Laser System Product Code GEX Predicate Devices Biolitec's Ceralas D 980nm Diode Laser (Models DI 5, D25) (K072779) Quanta System Diode Medical Laser Family (K072034) 22 \\C… | 2008 |
| * | K072034 | Diode Medical Laser Family, Models 4, 6, 30Summary page 1…ct Code GEX Predicate Devices Biolitec's Ceralas D 980nm Diode Laser (Models DI 5, D25) (K072779) Quanta System Diode Medical Laser Family (K072034) 22 \\C- 061213/000001 -2707069 v3… | 2007 |
What descends from it? (34)
See all 346 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 13 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 7 of the 184 ancestors have a recall of any class.
- Of its descendants, K094049 (Dental Photonics, Inc., 2010) has gone furthest, with 23 descendants of its own.
- 7 other devices also cite its predicate K072779.
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 D 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 D 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…
Read the full statement (722 words)
The Ceralas D 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 D 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, and cardiothoracic surgery, and ophthalmology. This Ceralas D 980 is specifically indicated for 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
* Herniorapphy
* 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
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
Cardiothoracic Surgery:
Incision, excision, vaporization, ablation, hemostasis, and 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/K081015 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081015: Ceralas D 980NM Diode Laser, Models D15 and D25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081015
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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