510(k) · Cleared
ClearedSkyPulse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fotona D.O.O. · GEX Powered Laser Surgical Instrument
Cleared on Mar 27, 2020 as substantially equivalent to K191554 (Fotona D.O.O., 2019) and 12 other predicates after an 88-day review. Its family tree reaches back 22 generations to 1995. 11 later devices descend from it.
- Decided
- Mar 27, 2020
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 22 generations to K943450 (1995). 632 ancestors in all, the oldest K771218 (1978). 11 later devices descend from it, 6 citing it directly.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 2 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 1 generation backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- This deviceK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · cites it directly · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · cites it directly · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK230274 Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK241791 Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D…Gigaalaser Company, Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK234004 Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd. · 2025
Show all 22 generations
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 18 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 17 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 16 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 15 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 14 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 11 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 10 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 9 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 8 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 7 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 6 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 5 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 4 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 3 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 2 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 1 generation backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- This deviceK193656 SkyPulseFotona D.O.O. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · cites it directly3descendants
- K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024 · cites it directly2descendants
- K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd. · 2023 · cites it directly2descendants
- K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd. · 2025 · cites it directly1descendant
- K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd. · 2025 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −21 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −18 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −17 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −16 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −15 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −14 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −11 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −10 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −9 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −8 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −7 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −6 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −5 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −4 | 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 | — |
| −2 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −1 | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | 2018 | — |
| 0 (this device) | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +1 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +1 | K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
| +1 | K230274 | Medical Diode Laser (M2) | Wuhan Pioon Technology Co., Ltd. | 2023 | — |
| +1 | K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS… | Gigaalaser Company, Ltd. | 2025 | — |
| +1 | K234004 | Medical diode laser systems (CHARISMA, REGAL) | Reveal Lasers, Ltd. | 2025 | — |
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 | 32 | 0 |
| 1998 | 38 | 0 |
| 1999 | 29 | 0 |
| 2000 | 39 | 0 |
| 2001 | 40 | 0 |
| 2002 | 48 | 0 |
| 2003 | 52 | 0 |
| 2004 | 39 | 0 |
| 2005 | 35 | 0 |
| 2006 | 23 | 0 |
| 2007 | 22 | 0 |
| 2008 | 28 | 0 |
| 2009 | 18 | 0 |
| 2010 | 11 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 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? (13)
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 |
|---|---|---|---|
| * | K191554 | LightWalker Laser System FamilySummary page 7…eral and Plastic Surgery 21 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICES • Fotona LightWalker Laser System Family (K191554), • Biolase WaterLase iPlus Laser System Family (K190319), • Fotona Dynamis Pro Laser System Family (K182088), •… | 2019 |
| * | K190319 | Waterlase Laser System FamilySummary page 7…, Class II Product Code: GEX PREDICATE DEVICES • Fotona LightWalker Laser System Family (K191554), • Biolase WaterLase iPlus Laser System Family (K190319), • Fotona Dynamis Pro Laser System Family (K182088), • Fox Q-810, Q-980 and Q-1064 Diode Laser (K073322), • G.… | 2019 |
| * | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroSummary page 7…• Fotona LightWalker Laser System Family (K191554), • Biolase WaterLase iPlus Laser System Family (K190319), • Fotona Dynamis Pro Laser System Family (K182088), • Fox Q-810, Q-980 and Q-1064 Diode Laser (K073322), • G.N.S neoLaser neoV Diode Laser Family (K133006), • De… | 2018 |
| * | K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810Summary page 7…• Biolase WaterLase iPlus Laser System Family (K190319), • Fotona Dynamis Pro Laser System Family (K182088), • Fox Q-810, Q-980 and Q-1064 Diode Laser (K073322), • G.N.S neoLaser neoV Diode Laser Family (K133006), • Dentsply Sirona SIROLaser Advance+ (K170500), • Fotona… | 2008 |
| * | K133006 | Neov Diode Laser FamilySummary page 7…19), • Fotona Dynamis Pro Laser System Family (K182088), • Fox Q-810, Q-980 and Q-1064 Diode Laser (K073322), • G.N.S neoLaser neoV Diode Laser Family (K133006), • Dentsply Sirona SIROLaser Advance+ (K170500), • Fotona XD Diode Laser System (K083034), • AMD Picasso Plus… | 2014 |
| * | K170500 | SIROLaser Advance+Summary page 7…182088), • Fox Q-810, Q-980 and Q-1064 Diode Laser (K073322), • G.N.S neoLaser neoV Diode Laser Family (K133006), • Dentsply Sirona SIROLaser Advance+ (K170500), • Fotona XD Diode Laser System (K083034), • AMD Picasso Plus (K152939), • MedX Electronics MedX LPS 200 Porta… | 2017 |
| * | K083034 | Fotona XD-2 Diode Laser System, Model MD01-2FSummary page 7…de Laser (K073322), • G.N.S neoLaser neoV Diode Laser Family (K133006), • Dentsply Sirona SIROLaser Advance+ (K170500), • Fotona XD Diode Laser System (K083034), • AMD Picasso Plus (K152939), • MedX Electronics MedX LPS 200 Portable Laser (Oralase) (K082707), • Biolase e… | 2009 |
| * | K152939 | Picasso Plus, Picasso Lite PlusSummary page 7…oLaser neoV Diode Laser Family (K133006), • Dentsply Sirona SIROLaser Advance+ (K170500), • Fotona XD Diode Laser System (K083034), • AMD Picasso Plus (K152939), • MedX Electronics MedX LPS 200 Portable Laser (Oralase) (K082707), • Biolase ezlase (K083069), • Biolase Epi… | 2015 |
| * | K082707 | Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable LaserSummary page 7…r Advance+ (K170500), • Fotona XD Diode Laser System (K083034), • AMD Picasso Plus (K152939), • MedX Electronics MedX LPS 200 Portable Laser (Oralase) (K082707), • Biolase ezlase (K083069), • Biolase Epic Pro (K163128), • G.N.S neoLaser neoV980 & neoV1470 Diode Lasers (K… | 2008 |
| * | K083069 | Ezlase 10WSummary page 7…na XD Diode Laser System (K083034), • AMD Picasso Plus (K152939), • MedX Electronics MedX LPS 200 Portable Laser (Oralase) (K082707), • Biolase ezlase (K083069), • Biolase Epic Pro (K163128), • G.N.S neoLaser neoV980 & neoV1470 Diode Lasers (K152722), • Sciton Joule Mult… | 2008 |
| * | K163128 | Epic ProSummary page 7…• AMD Picasso Plus (K152939), • MedX Electronics MedX LPS 200 Portable Laser (Oralase) (K082707), • Biolase ezlase (K083069), • Biolase Epic Pro (K163128), • G.N.S neoLaser neoV980 & neoV1470 Diode Lasers (K152722), • Sciton Joule Multi-Platorform System (K101916).… | 2017 |
| * | K152722 | neoV980 & neoV1470 Diode LasersSummary page 7…LPS 200 Portable Laser (Oralase) (K082707), • Biolase ezlase (K083069), • Biolase Epic Pro (K163128), • G.N.S neoLaser neoV980 & neoV1470 Diode Lasers (K152722), • Sciton Joule Multi-Platorform System (K101916). 510(k) Submission: Fotona SkyPulse Laser Platform… | 2015 |
| * | K101916 | Joule Multi-Platform SystemSummary page 7…ase ezlase (K083069), • Biolase Epic Pro (K163128), • G.N.S neoLaser neoV980 & neoV1470 Diode Lasers (K152722), • Sciton Joule Multi-Platorform System (K101916). 510(k) Submission: Fotona SkyPulse Laser Platform 1/10 DEVICE DESCRIPTION The… | 2011 |
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202991 | Fotona XPulse Pro Laser Platform | 2021 | 3 |
| K240179 | Medical Diode Laser (Model: L2) | 2024 | 2 |
| K230274 | Medical Diode Laser (M2) | 2023 | 2 |
| K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D… | 2025 | 1 |
| K234004 | Medical diode laser systems (CHARISMA, REGAL) | 2025 | 1 |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | 2022 | 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 25 years and passes through 9 companies; a new generation was cleared every 11 months on median.
- 30 of the 632 ancestors have a recall of any class.
- Of its descendants, K202991 (Fotona D.O.O., 2021) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K191554.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
2940 nm Er:YAG Laser in dentistry: -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…
Read the full statement (834 words)
2940 nm Er:YAG Laser in dentistry:
-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 calculi 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
-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
-Gingivoplasty
-Implant recovery
-Root canal debridement and cleaning
-Soft tissue crown lengthening
-Laser root canal disinfection after endodontic treatment
2940 nm Er:YAG Laser in dermatology and other surgical areas:
-Dermatology and Plastic Surgery Indications: Skin resurfacing, epidermal nevi, verrucae, skin tags, keratoses, treatment of wrinkles
-ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia
-Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy
-General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation
-Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae
-Ophthalmology Indications: Soft tissue surrounding the eye
-Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma
-Genitourinary Indications: Lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon
1064 nm Diode Laser in dentistry:
-Excisional and incisional biopsies
-Excision and vaporization of herpes simplex I and II
-Frenectomy and frenotomy
-Gingivectomy
-Gingivoplasty
-Gingival incision and excision
-Hemostasis
-Implant recovery
-Operculectomy
-Pulpotomy and pulpotomy as an adjunct to root canal therapy
-Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
-Sulcular debridement or soft tissue curettage (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)
-Treatment of aphthous ulcers and herpetic lesions
1064 nm Diode Laser in dermatology and other surgical areas:
-General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal.
-Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.
-Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.)
1064 nm Diode Laser in therapy:
-Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.
670 nm Diode Laser in low level laser therapy:
-Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
808 nm Diode Laser in dentistry:
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
-Fibroma removal
-Frenectomy and frenotomy
-Oral papillectomies
-Soft tissue crown lengthening
-Treatment of aphthous ulcers
-Treatment of herpetic lesions
Periodontology:
-Laser soft tissue curettage,
-Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket
Cosmetic Dentistry:
-Laser-assisted bleaching/whitening of the teeth,
-Light activation for bleaching materials for teeth whitening
Implant recovery
808 nm Diode Laser in therapy:
-Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
980 nm Diode Laser in dentistry:
-Gingival troughing
-Crown lengthening
-Gingivoplasty
-Coagulation
-Hemostasis of donor site
-Implant recovery
-Implant uncovery
-Soft tissue curettage
-Sulcular debridement
-Biopsy
-Frenectomy
-Operculectomy
-Exposure of unerupted teeth
-Pulpotomy
-Treatment of aphthous ulcers
-Excision of lesions
-Light activation of bleaching materials for teeth whitening
1470 nm Diode Laser:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
1940 nm Diode Laser:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193656: SkyPulse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193656
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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