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 Jan 24, 2008 as substantially equivalent to K993911 (Ceram Optec, Inc., 2000) and 6 other predicates after a 118-day review. Its family tree reaches back 4 generations to 1992. 153 later devices descend from it.
- Decided
- Jan 24, 2008
- Review
- 118 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 4 generations to K922901 (1992). 14 ancestors in all. 153 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 3 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 2 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 1 generation backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- This deviceK072779 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- Descendant · cites it directly · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- Descendant · 4 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · 3 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
Showing 5 of 153 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 153 · See all- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −3 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −2 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −1 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| 0 (this device) | K072779 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| +1 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| +4 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +3 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 0 |
| 2021 | 10 | 0 |
| 2022 | 18 | 0 |
| 2023 | 12 | 0 |
| 2024 | 16 | 0 |
| 2025 | 18 | 0 |
| 2026 | 13 | 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? (8)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993911 | Ceralas D Diode Laser System, Model D15, D25,D50Summary page 1…aser Classification Number/Name 878.4810 Laser, Surgical Diode Laser System Product Code GEX Predicate Devices Ceralas Diode Laser System (Model D) (K993911) Ceralas D 980nm Diode Laser (Models D15, D25) (K032863) Cynosure SmartLipo Laser Nd:YAG Laser System (K062321) \\\DC 061213/… | 2000 |
| * | K032863 | Ceralas D 980 Diode Laser System, Models D15, D25, D50Summary page 1…Laser, Surgical Diode Laser System Product Code GEX Predicate Devices Ceralas Diode Laser System (Model D) (K993911) Ceralas D 980nm Diode Laser (Models D15, D25) (K032863) Cynosure SmartLipo Laser Nd:YAG Laser System (K062321) \\\DC 061213/000001 2669146 v1 Ce… | 2004 |
| * | K062321 | Smartlipo ND:Yag LaserSummary page 1…Predicate Devices Ceralas Diode Laser System (Model D) (K993911) Ceralas D 980nm Diode Laser (Models D15, D25) (K032863) Cynosure SmartLipo Laser Nd:YAG Laser System (K062321) \\\DC 061213/000001 2669146 v1 CealsDideLse Ssem(Mdl 15 K O9h87tf5%48§ Ceralas Dio… | 2006 |
| Kept off the family tree | K998305 | Ceralas Diode Laser System (Model D15) Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…em (K062321) \\\DC 061213/000001 2669146 v1 CealsDideLse Ssem(Mdl 15 K O9h87tf5%48§ Ceralas Diode Laser System (Model D15) (K998305) Ceralas Diode Laser System (Model D15) (K991891) Ceralas Diode Laser Systems (Model D15) (K963002) Intended Use / Indications f… | |
| * | K991891 | Ceralas Diode Laser System, Model Ceralas D15Summary page 2…CealsDideLse Ssem(Mdl 15 K O9h87tf5%48§ Ceralas Diode Laser System (Model D15) (K998305) Ceralas Diode Laser System (Model D15) (K991891) Ceralas Diode Laser Systems (Model D15) (K963002) Intended Use / Indications for Use The Ceralas D 980 is intended for deliver… | 1999 |
| * | K993002 | Ceralas D 980NM Diode Laser System, Model D15 Our reading of the summary gave K963002, FDA’s number for Active Androstenedione Eia (Diagnostic Systems Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ceralas Diode Laser Systems (Model D15)”. | 1999 |
| * | K964497 | Ceralas Diode Laser System (Ceralas D15)Summary page 6…formance Data No performance data is being submitted. Substantial Equivalence The Ceralas D is as safe and effective as Biolitec's cleared Ceralas Diode Laser System (K964497, K99391 1, K032863, K983058, K99189 1, K993002), as well as the Cynosure SmartLipo Laser Nd:YAG Laser System (K062321). The Ceral… | 1997 |
| * | K983058 | Ceralas D Laser System, Model # Ceralas D15Summary page 6…e data is being submitted. Substantial Equivalence The Ceralas D is as safe and effective as Biolitec's cleared Ceralas Diode Laser System (K964497, K99391 1, K032863, K983058, K99189 1, K993002), as well as the Cynosure SmartLipo Laser Nd:YAG Laser System (K062321). The Ceralas D has the same intended u… | 1998 |
What descends from it? (153)
See all 1538 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081352 | Profile Multi-Platform System | 2008 | 112 |
| K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25 | 2008 | 34 |
| K080567 | Palomar Aspire Laser Platform | 2008 | 10 |
| K091562 | Doctor Smile a-810 and B-980 Lasers | 2009 | 8 |
| K102036 | Doctor Surgery Diode Lasers Family | 2010 | 7 |
| K082721 | Laserpro 810, 940 and 980 Diode Laser Systems | 2008 | 7 |
| K140120 | EPIC 10 | 2014 | 1 |
| K082263 | Ceralas E 980NM Diode Laser, Models E15/980 and E30/980 | 2008 | 1 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K081352 (Sciton, Inc, 2008) has gone furthest, with 112 descendants of its own.
- 2 other devices also cite its predicate K993911.
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 (611 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. This Ceralas D 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
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
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
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/K072779 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072779: 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/K072779
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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