510(k) · Cleared
ClearedCURATIVE980 Diode Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oroscience, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 15, 2008 as substantially equivalent to K072034 (Quanta System Spa, 2007) and 5 other predicates after a 51-day review. Its family tree reaches back 15 generations to 1995.
- Decided
- Oct 15, 2008
- Review
- 51 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K943450 (1995). 195 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- 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 deviceK082445 CURATIVE980 Diode LaserOroscience, Inc. · 2008
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 deviceK082445 CURATIVE980 Diode LaserOroscience, Inc. · 2008
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) | K082445 | CURATIVE980 Diode Laser | Oroscience, Inc. | 2008 | — |
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 | 4 | 0 |
| 1992 | 5 | 0 |
| 1993 | 7 | 0 |
| 1994 | 9 | 0 |
| 1995 | 14 | 0 |
| 1996 | 17 | 0 |
| 1997 | 22 | 0 |
| 1998 | 14 | 0 |
| 1999 | 8 | 0 |
| 2000 | 14 | 0 |
| 2001 | 13 | 0 |
| 2002 | 17 | 0 |
| 2003 | 13 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 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? (6)
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 |
|---|---|---|---|
| * | K072034 | Diode Medical Laser Family, Models 4, 6, 30Summary page 1…lassification Names: Laser Powered Surgical Instruments (and Accessories) III. Predicate Devices • Quanta System Diode Medical Laser - 808, 940, or 980 nm (K072034) * Hoya ConBio DioDent MICRO - 980 run (K063384) * Biolitec Ceralas 980 nmn / SmilePro 980 (K050824) *… | 2007 |
| * | K063384 | Diodent Micro Dental Laser System, Models 810 and 980Summary page 1…and Accessories) III. Predicate Devices • Quanta System Diode Medical Laser - 808, 940, or 980 nm (K072034) * Hoya ConBio DioDent MICRO - 980 run (K063384) * Biolitec Ceralas 980 nmn / SmilePro 980 (K050824) * Laser Dental Innovations LiteSaberTM 2000 (K993942)… | 2007 |
| * | K050824 | 100W Ceralas D 980 Laser System, Model D100Summary page 1…a System Diode Medical Laser - 808, 940, or 980 nm (K072034) * Hoya ConBio DioDent MICRO - 980 run (K063384) * Biolitec Ceralas 980 nmn / SmilePro 980 (K050824) * Laser Dental Innovations LiteSaberTM 2000 (K993942) * Laser Dental Innovations StarLite 2006 (K052604)… | 2005 |
| * | K993942 | Litesaber 2000Summary page 1…* Hoya ConBio DioDent MICRO - 980 run (K063384) * Biolitec Ceralas 980 nmn / SmilePro 980 (K050824) * Laser Dental Innovations LiteSaberTM 2000 (K993942) * Laser Dental Innovations StarLite 2006 (K052604) * B&W Tek, Inc. BWF-5 Medical Laser Series (K062363) IV.… | 2000 |
| * | K052604 | Starlite 2006Summary page 1…* Biolitec Ceralas 980 nmn / SmilePro 980 (K050824) * Laser Dental Innovations LiteSaberTM 2000 (K993942) * Laser Dental Innovations StarLite 2006 (K052604) * B&W Tek, Inc. BWF-5 Medical Laser Series (K062363) IV. Product Description The Curative980 Diode Lase… | 2005 |
| * | K062363 | BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NMSummary page 1…* Laser Dental Innovations LiteSaberTM 2000 (K993942) * Laser Dental Innovations StarLite 2006 (K052604) * B&W Tek, Inc. BWF-5 Medical Laser Series (K062363) IV. Product Description The Curative980 Diode Lasers are comprised of the following main components: *… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 195 ancestors have a recall of any class.
- 6 other devices also cite its predicate K072034.
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 Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended to deliver laser energy for incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery as follows: Dental Surgery Indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue (intraoral and extraoral) including marginal and inter-dental…
Read the full statement (274 words)
The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended to deliver laser energy for incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery as follows:
Dental Surgery
Indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue (intraoral and extraoral) including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:
* Biopsy
* Excisional and incisional biopsies
* Excision of lesions
* Exposure of unerupted/partially erupted teeth
* Fibroma removal
* Frenectomy
* Frenotomy
* Gingival troughing for crown impressions
* Gingival troughing
* Gingivectomy
* Gingivoplasty
* Gingival incision and excision
* Hemostasis and coagulation
* Hemostasis of donor site
* Implant recovery
* Removal of granulation tissue
* Laser assisted flap surgery
Dental Surgery - Continued
* Debridement of diseased epithelial lining
* Treatment of aphthous ulcers
* Sulcular debridement (removal of diseased or inflamed soft-tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
* Laser soft tissue curettage
* Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
* Operculectomy
* Incision and drainage of abscess
* Oral papillectomies; papillectomy
* Removal of hyperplastic tissues
* Pulpotomy
* Pulpotomy as an adjunct to root canal therapy
* Reduction of gingival hypertrophy
* Reduction of bacterial level (decontamination) and inflammation
* Soft tissue crown lengthening; crown lengthening
* Tissue retraction for impressions
* Leukoplakia
* Vestibuloplasty
* Light activation of bleaching materials for teeth whitening.
* Laser-assisted bleaching/whitening for teeth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082445: CURATIVE980 Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082445
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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