510(k) · Cleared
ClearedUltrafast, Ultrafast Plus, Ultrafast Lite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentlight, Inc. · NVK Laser, Dental, Soft Tissue
Cleared on Feb 26, 2021 as substantially equivalent to K081214 (Zap Lasers, LLC, 2008) and 1 other predicate after a 275-day review. Its family tree reaches back 21 generations to 1995.
- Decided
- Feb 26, 2021
- Review
- 275 days
- Class
- Class II
- Product code
- NVK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K943450 (1995). 266 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK122020 Photon Photon PlusZolar Technology & Mfg Co., Inc. · 2013
- 2 generations backK162114 Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016
- 1 generation backK200693 K2 MobileHulaser, Inc. · 2020
- This deviceK201387 Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc. · 2021
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 8 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 7 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 6 generations backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- 5 generations backK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- 4 generations backK111689 StlaseDental Photonics, Inc. · 2012
- 3 generations backK122020 Photon Photon PlusZolar Technology & Mfg Co., Inc. · 2013
- 2 generations backK162114 Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016
- 1 generation backK200693 K2 MobileHulaser, Inc. · 2020
- This deviceK201387 Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −8 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −7 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −6 | K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| −5 | K094049 | Stlase Diode Laser | Dental Photonics, Inc. | 2010 | — |
| −4 | K111689 | Stlase | Dental Photonics, Inc. | 2012 | — |
| −3 | K122020 | Photon Photon Plus | Zolar Technology & Mfg Co., Inc. | 2013 | — |
| −2 | K162114 | Photon, Photon Plus | Zolar Technology & Mfg Co., Inc. | 2016 | — |
| −1 | K200693 | K2 Mobile | Hulaser, Inc. | 2020 | — |
| 0 (this device) | K201387 | Ultrafast, Ultrafast Plus, Ultrafast Lite | Dentlight, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 15 | 0 |
| 1996 | 18 | 0 |
| 1997 | 24 | 0 |
| 1998 | 16 | 0 |
| 1999 | 12 | 0 |
| 2000 | 18 | 0 |
| 2001 | 19 | 0 |
| 2002 | 24 | 0 |
| 2003 | 19 | 0 |
| 2004 | 14 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K081214 | Styla Microlaser and StylaorthoSummary page 4…Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology (878.4810) Product Code: GEX 3. PRIMARY PREDICATE DEVICE Styla Microlaser (K081214), manufactured by Zap Lasers, LLC. REFERENCE DEVICE K2 Mobile (K200693), manufactured by Hu Laser. 4. INTENDED USE / INDI… | 2008 |
| * | K200693 | K2 Mobile Cleared while this submission was under review Summary page 4…rmatology (878.4810) Product Code: GEX 3. PRIMARY PREDICATE DEVICE Styla Microlaser (K081214), manufactured by Zap Lasers, LLC. REFERENCE DEVICE K2 Mobile (K200693), manufactured by Hu Laser. 4. INTENDED USE / INDICATIONS FOR USE Dental soft tissue indications: incision, excision, vapori… | 2020 |
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 26 years and passes through 10 companies; a new generation was cleared every 11 months on median.
- 11 of the 266 ancestors have a recall of any class.
- 7 other devices also cite its predicate K081214.
How does its category compare?
All NVK devicesNVK Laser, Dental, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Dental soft tissue indications: incision, excision, vaporization, ablation, and coagulation of oral soft tissues including the following: Gingival troughing for crown impression Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral…
Read the full statement (135 words)
Dental soft tissue indications: incision, excision, vaporization, ablation, and coagulation of oral soft tissues including the following:
Gingival troughing for crown impression
Gingivectomy
Gingivoplasty
Gingival incision and excision
Hemostasis and coagulation
Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Frenectomy and frenotomy
Implant recovery
Incision and drainage of abscess
Leukoplakia
Operculectomy
Oral papillectomies
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Treatment of canker sores, herpetic and ulcers
Vestibuloplasty
Tissue retraction for impression
Laser periodontal indications including:
Sulcular debridernent (curettage, removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility).
Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket.
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/K201387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201387: Ultrafast, Ultrafast Plus, Ultrafast Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201387
Report an extraction error
Are you the manufacturer?
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