510(k) · Cleared
ClearedSOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Soga Technology Co., Ltd. · NVK Laser, Dental, Soft Tissue
Cleared on May 19, 2026 as substantially equivalent to K242202 (Fotona D.O.O., 2024) and 1 other predicate after a 232-day review. Its family tree reaches back 25 generations to 1995.
- Decided
- May 19, 2026
- Review
- 232 days
- Class
- Class II
- Product code
- NVK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 25 generations to K943450 (1995). 602 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations between
- 3 generations backK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- 2 generations backK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- 1 generation backK242202 LightWalker Laser System FamilyFotona D.O.O. · 2024
- This deviceK253309 SOGA Lasers therapy system family of Aurora handpiece (Aurora-S)…Shenzhen Soga Technology Co., Ltd. · 2026
Show all 25 generations
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 24 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 21 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 20 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 19 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 18 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 17 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 14 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 13 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 12 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 11 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 10 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 9 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 8 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 7 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 6 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 5 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 4 generations backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- 3 generations backK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- 2 generations backK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- 1 generation backK242202 LightWalker Laser System FamilyFotona D.O.O. · 2024
- This deviceK253309 SOGA Lasers therapy system family of Aurora handpiece (Aurora-S)…Shenzhen Soga Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −24 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −21 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −20 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −19 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −18 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −17 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −14 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −13 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −12 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −11 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −10 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −9 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −8 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −7 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −6 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −5 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −4 | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | 2018 | — |
| −3 | K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020 | — |
| −2 | K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021 | — |
| −1 | K242202 | LightWalker Laser System Family | Fotona D.O.O. | 2024 | — |
| 0 (this device) | K253309 | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers… | Shenzhen Soga Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 9 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 27 | 0 |
| 1995 | 26 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 35 | 0 |
| 1999 | 29 | 0 |
| 2000 | 38 | 0 |
| 2001 | 38 | 0 |
| 2002 | 45 | 0 |
| 2003 | 51 | 0 |
| 2004 | 38 | 0 |
| 2005 | 34 | 0 |
| 2006 | 19 | 0 |
| 2007 | 22 | 0 |
| 2008 | 26 | 0 |
| 2009 | 15 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 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 NVK? 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 NVK device
- #1 K210367 D-Laser Blue, D-Laser 16score 20.7 · 20 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 |
|---|---|---|---|
| * | K242202 | LightWalker Laser System FamilySummary page 6…LightWalker Laser System D-Laser Blue Family 510(K) Number K242202 K210367 Model:ILaser III Pro Predicate Devices Gu… | 2024 |
| * | K210367 | D-Laser Blue, D-Laser 16Summary page 6…D-Laser Blue Family 510(K) Number K242202 K210367 Model:ILaser III Pro Predicate Devices Guilin Woodpecker Medical… | 2022 |
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 31 years and passes through 10 companies; a new generation was cleared every 12 months on median.
- 30 of the 602 ancestors have a recall of any class.
How does its category compare?
All NVK devicesNVK Laser, Dental, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NVK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVK
139in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NVK
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NVK
1in 2024
MAUDE reports naming product code NVK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 4 | 277 | 0 | 0 |
| 2022 | 5 | 139 | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Aurora-S: • Intra-oral soft tissue surgery (incision, excision, ablation, coagulation); • Leukoplakia; • Pulpotomy as adjunct to root canal retreatment; • Pulp extirpation; • Removal of fibromae; • Removal of granulated tissue; • Caries removal, cavity preparation, enamel roughening; • Sulcular debridement; • Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement; • Cutting…
Read the full statement (419 words)
Aurora-S:
• Intra-oral soft tissue surgery (incision, excision, ablation, coagulation);
• Leukoplakia;
• Pulpotomy as adjunct to root canal retreatment;
• Pulp extirpation;
• Removal of fibromae;
• Removal of granulated tissue;
• Caries removal, cavity preparation, enamel roughening;
• Sulcular debridement;
• Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement;
• Cutting, shaving, contouring and resection of oral osseous tissue (bone);
• Osteotomy, osseous crown lengthening, osteoplasty;
• Apicectomy surgery;
• Removal of subgingival calculus in periodontal pockets with periodontitis by closed or open curettage;
• Laser removal of porcelain and ceramic crowns and veneers;
• Flap preparation – incision of soft-tissue to prepare a flap and expose the bone;
• Cutting bone to prepare a window access to the apex (apices) of the root(s);
• Root-end preparation for retrofill amalgam or composite;
• Full thickness flap;
• Partial thickness flap;
• Split thickness flap;
• Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket;
• Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium;
• Excisional and incisional biopsies;
• Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions);
• Frenectomy and frenotomy;
• Gingival troughing for crown impressions;
• Gingivectomy;
• Gingivoplasty;
• Implant recovery;
• Root canal debridement and cleaning;
• Soft tissue crown lengthening;
• Laser root canal disinfection after endodontic treatment
ILaser III Pro:
SOGA Lasers therapy system family of the Dental diode laser is intended for intra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: 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; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket.sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the sulcus periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; herpetic ulcers of the oral mucosa; laser soft tissue curettage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253309: SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253309
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026