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 genis, 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, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cattillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal.
-Podiatry (ablation, vaporization, incision, 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, 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

Device Description

The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen. The console allows simultenous attachment of a solid state laser module and a diode module with up to three selectable diode laser wavelengths.
The following therapeutic laser modules are currently available with the SkyPulse platform: 2940 nm Er:YAG Laser Module, 1064 nm Diode Laser Module, 808 nm Diode Laser Module, 670 nm Diode Laser Module, 980 nm Diode Laser Module, 1470 nm Diode Laser Module and 1940 nm Diode Laser Module. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided either through an articulated arm to an optical handpiece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.

AI/ML Overview

This FDA 510(k) summary describes a multi-wavelength laser platform (Fotona SkyPulse Laser Platform) and its substantial equivalence to previously cleared medical laser systems. The document states that no clinical testing was needed for this device. Therefore, the questions related to clinical study design, sample size, ground truth establishment, expert adjudication, and MRMC studies are not applicable.

The acceptance criteria for this device are based on demonstrating that it meets various mandatory and voluntary standards for medical electrical equipment, particularly for laser surgical equipment. The "study" proving the device meets these criteria is laboratory testing to ensure it adheres to these standards and that its design specifications align with those of predicate devices.

Here's the breakdown of the requested information, adapted to reflect that no clinical study was performed:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a laser device and no clinical data is presented, the "acceptance criteria" are embodied in the compliance with recognized standards, and the "reported device performance" refers to the device meeting the technical specifications and safety requirements outlined in those standards. The document provides tables comparing the technical specifications of the Fotona SkyPulse Laser Platform with several predicate devices, serving as evidence of similar performance and characteristics.

Acceptance Criterion (Standard Compliance)	Reported Device Performance (as demonstrated by comparison and lab testing)
EN 60601-1:2006 + A1:2013	Meets general requirements for basic safety and essential performance.
EN 60601-1-2:2015	Meets electromagnetic compatibility requirements.
EN 60601-2-22:2013	Meets particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment.
EN 60601-1-6:2010 + A1:2015	Meets general requirements for basic safety and essential performance - Collateral standard: Usability.
EN 62366:2008 + A1:2015	Meets requirements for the application of usability engineering to medical devices.
EN 60825-1:2014	Meets requirements for safety of laser products and equipment classification.
EN ISO 14971:2012	Application of risk management to medical devices demonstrated.
EN 62304:2006 + A1:2015	Meets medical device software life-cycle processes.
EN ISO 17664:2004	Meets sterilization requirements (information for processing resterilizable medical devices). (Transition to newer version underway)
EN ISO 10993-1:2009	Meets biological evaluation of medical devices (evaluation and testing within a risk management process). (Transition to newer version underway)
Technical Specifications (Tables 1-7)	Device's energy source, wavelength, aiming beam, power, energy per pulse, pulse width, repetition rate, delivery system, and user interface are comparable to predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: This is not applicable as no clinical test set was used for this 510(k) submission. The evaluation was based on demonstrating compliance with recognized standards and comparison to predicate devices, supported by laboratory testing.
Data Provenance: Not applicable for a clinical test set. The technical specifications and performance data are derived from the device's design, manufacturing, and laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as no clinical test set or human-interpreted ground truth was used. The ground truth for device safety and performance is established by adherence to engineering specifications and international/national standards, verified through laboratory testing.

4. Adjudication method for the test set

Not applicable as no clinical test set requiring human adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case comparative effectiveness study was not done. The device is a laser system, not an AI-assisted diagnostic tool that would typically undergo such a study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a laser surgical instrument, and the concept of "standalone performance" in the context of an algorithm or AI without human-in-the-loop performance is not relevant. Its performance is assessed through its technical specifications and safety features.

7. The type of ground truth used

The "ground truth" for this submission is adherence to technical specifications, engineering design, and compliance with recognized national and international electrical, medical device, and laser safety standards, as demonstrated through laboratory testing.

8. The sample size for the training set

Not applicable as this is not a machine learning device and therefore does not have a training set.

9. How the ground truth for the training set was established

Not applicable as this is not a machine learning device and therefore does not have a training set.

In summary, the Fotona SkyPulse Laser Platform's acceptance was based on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and compliance with a comprehensive list of medical device and laser safety standards, verified by laboratory testing, rather than through clinical studies or AI model evaluations.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 27, 2020

Fotona d.o.o. Marko Berdajs Ouality Assurance and Regulatory Affairs Manager Stegne 7 Ljubljana, SI-1000 Si

Re: K193656 Trade/Device Name: SkyPulse Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: December 24, 2019 Received: December 30, 2019

Dear Marko Berdajs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Mavadia-Shukla, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193656

Device Name SkyPulse Laser Platform

Indications for Use (Describe)
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

General Surgery Indications: Surgical incision, 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

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-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 genis, 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, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cattillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal.

-Podiatry (ablation, vaporization, incision, 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

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Periodontology:

-Laser soft tissue curettage,
-Laser removal of diseased, 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

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

SUBMITTER'S INFORMATION

Submitter:	Fotona d.o.o.Stegne 71000 Ljubljana, SloveniaPhone: +386 1 5009 100Fax: +386 1 5009 200
Contact Person:	Marko Berdajs, Quality Assurance and Regulatory Affairs ManagerPhone: +386 1 5009 119E-mail: marko.berdajs@fotona.com
Date:	March 26, 2020

DEVICE INFORMATION

Device Trade Name:	Fotona SkyPulse Laser Platform
Common name:	Medical Laser System
Classification name:	GEX-Powered Laser Surgical Instrument, General and Plastic Surgery21 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),
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 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).

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DEVICE DESCRIPTION

The following therapeutic laser modules are currently available with the SkyPulse platform: 2940 nm Er:YAG Laser Module, 1064 nm Diode Laser Module, 808 nm Diode Laser Module, 670 nm Diode Laser Module, 980 nm Diode Laser Module, 1470 nm Diode Laser Module and 1940 nm Diode Laser Module. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided either through an articulated arm to an optical handpiece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.

INTENDED USE

The Fotona SkyPulse Laser Platform, and its accessories, will be marketed for the following indications:

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 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, inflamed and necrosed soft tissue within the periodontal pocket
. Removal of highly inflamed edematous tissue affected by bacteria penetration of the

{8}------------------------------------------------

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 .
Gingivoplastv
. 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

{9}------------------------------------------------

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:
- o Gingival troughing for crown impression
- Gingivectomy o
- O Gingivoplasty
- Gingival incision and excision o
- O Hemostasis and coagulation
- o Excisional and incisional biopsies
- Fibroma removal o
- Frenectomy and frenotomy o
- Oral papillectomies o
- Soft tissue crown lengthening o
- Treatment of aphthous ulcers o
- Treatment of herpetic lesions o
. Periodontology:
- Laser soft tissue curettage o
- Laser removal of diseased, inflamed and necrosed soft tissue within the o periodontal pocket
Cosmetic Dentistry: .
- Laser-assisted bleaching/whitening of the teeth o
- Light activation for bleaching materials for teeth whitening o
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.

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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 .

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The Fotona SkyPulse Laser Platform has either identical or similar applicable technological and design characteristics (design, chemical composition, energy source, wavelength, active medium, cooling system, power supply, beam delivery, controls, housing) as the previously cleared Fotona LightWalker Laser System Family (K191554), Biolase WaterLase Laser System Family (K190319), Fotona Dynamis Pro Laser System Family (K182088), Sciton Joule Multi-Platorform System (K101916), 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 Portable Laser (Oralase) (K082707), Biolase ezlase (K083069), Biolase Epic Pro (K163128) and G.N.S neoLaser neoV980 & neoV1470 Diode Lasers (K152722). The output characteristics are for the intended use the same as those of the predicate devices. All lasers utilize Class II aiming beams which pose no hazard to the user. All systems are microprocessor controlled devices. The microprocessor control regulates normal operation, permits parameter selection and avoids hazard incidence. All systems utilize an internal closed loop water-air heat exchanger circuit for optimal thermal control of the laser cavity. The risks and benefits for the Fotona SkyPulse Laser Platform are identical to the predicate devices when used for similar clinical applications.

A comparison of the technical specifications for the intended use of the Fotona SkyPulse Laser Platform with the previously cleared devices is provided in Tables 1-7.

	Sciton JouleMulti-PlatorformSystem(K101916)	LightWalkerLaser SystemFamily(K191554)	WaterLaseLaser SystemFamily(K190319)	Dynamis ProLaser SystemFamilv(K182088)	FotonaSkyPulse LaserPlatform(thissubmission)
Energysource	Solid stateEr: YAG	Solid stateEr:YAG	Solid stateEr,Cr:YSGG	Solid stateEr: YAG	Solid stateEr: YAG
Wavelength	2940 nm	2940 nm	2780 nm	2940 nm	2940 nm
Aiming beam	Laser diode 630-680 nm	Laser diode 635nm/650 nm (red)Laser diode 635or 520-532 nmnm (red) ; < 1 mW(green); < 1 mW		Laser diode 635nm/650 nm (red) :< 1 mW	Laser diode 635nm/650 nm (red) :< l mW
Power	up to 20 W	Up to 20 W	Up to 10 W	Up to 20 W	Up to 5 W
Energy perpulse	Up to 1500 mJ	Up to 1500 mJ	Up to 600 mJ	Up to 3000 mJ	Up to 400 mJ
Pulse width	150-1500 µs	50-1000 µs	60-700 μs	50-1500 us	50-1000 us
Repetitionrate	Up to 100 Hz	Up to 100 Hz	Up to 100 Hz	Up to 50 Hz	Up to 40 Hz
Deliverysystem	Contact andnon-contacthandpiecesconnected to thesystem viaarticulated arm	Articulated arm	Fiber delivery	Articulated arm	Articulated arm
User interface	Touch screencontrol	Touch screencontrol	Touch screencontrol	Touch screencontrol	Touch screencontrol

Table 1: Comparison table of the technical specifications of Fotona SkyPulse Laser Platform with a flash-lamp pumped Er: YAG solid state laser module - with previously cleared devices.

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Table 2: Comparison table of the technical specifications of Fotona SkyPulse Laser Platform with the 1064 nm Diode Laser Module – with previously cleared devices.

	LightWalkerLaser SystemFamily(K191554)	Fox Q-810, Q-980and Q-1064 DiodeLaser(K073322)	neoV Diode LaserFamily(K133006)	Fotona SkyPulseLaser Platform(this submission)
Energy source	Solid state Nd:YAG	Solid state diode	Solid state diode	Solid state diode
Wavelength	1064 nm	1064 nm	1064 nm	1064 nm
Aiming beam	Laser diode 635nm/650 nm (red) or520-532 nm (green); < 1mW	Laser diode 532 nm(green) ; < 1 mW	Laser diode 532 nm	Laser diode 635nm/650 nm (red) ; < 1mW
Power	Up to 15 W	Up to 10 W	Up to 20 W	Up to 32 W
Pulse width	0.1- 25 ms; QCW	0.1 ms - CW	0.1 ms - 30 s; CW	10 ms - 10 s; CW
Repetition rate	Up to 100 Hz	Pulse interval: 0.1ms - CW	CW or up to 30 Hz	CW or up to 100Hz
Delivery system	Fiber delivery	Fiber delivery	Fiber delivery	Fiber delivery
User interface	Touch screencontrol	Touch screencontrol	Touch screencontrol	Touch screencontrol

Table 3: Comparison table of the technical specifications of Fotona SkyPulse Laser Platform with the 670 nm Diode Laser Module – with previously cleared device.

	SIROLaser Advance+(K170500)	Fotona SkyPulse Laser Platform(this submission)
Energy source	Solid state diode	Solid state diode
Wavelength	660 nm	670 nm
Power range	0.1 W	0.1-4 W
Pulse width	10 μs – 0.99 s; CW	10 ms – 10 s; CW
Repetition rate	CW or up to 20 kHz	CW or up to 100 Hz
Delivery system	Fiber delivery	Fiber delivery
User interface	Touch screen control	Touch screen control

Table 4: Comparison table of the technical specifications of Fotona SkyPulse Laser Platform with the 808 nm Diode Laser Module – with previously cleared devices.

	XD Diode LaserSystem(K083034)	Picasso Plus(K152939)	ezlase(K083069)	MedX LPS200 PortableLaser(Oralase)(K082707)	Fotona SkyPulseLaser Platform(this submission)
Energysource	Solid state diode	Solid statediode	Solid statediode	Solid statediode	Solid state diode
Wavelength	810 ± 10 nm	810 ± 10 nm	810 ± 15 nm	808 nm	808 nm
Power	Up to 7 W	Up to 7 W	Up to 4.5 W	Up to 0.25 W	0.1-33 W
Pulse width	0.025 - 25 ms; CW	20 ms -10 s;CW	0.06 ms - 10ms; CW	CW	10 ms - 10 s; CW
Repetitionrate	CW or 20 Hz - 10kHz	CW or up to 50Hz	CW or up to 10kHz	CW	CW or up to 100Hz
Delivery	Fiber delivery	Fiber delivery	Fiber delivery	Fiber delivery	Fiber delivery

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	XD Diode LaserSystem(K083034)	Picasso Plus(K152939)	ezlase(K083069)	MedX LPS200 PortableLaser(Oralase)(K082707)	Fotona SkyPulseLaser Platform(this submission)
system
Userinterface	Button control	Touch screencontrol	Touch screencontrol	Button control	Touch screencontrol

Table 5: Comparison table of the technical specifications of Fotona SkyPulse Laser Platform with the 980 nm Diode Laser Module – with previously cleared device.

	Epic Pro(K163128)	Fotona SkyPulse Laser Platform(this submission)
Energy source	Solid state diodeSolid state diode
Wavelength	980 ± 20 nm	980 nm
Power range	Up to 25 W	Up to 35 W
Pulse width	10 µs - 100 ms; CW10 ms - 10 s; CW
Repetition rate	CW or up to 20 kHzCW or up to 100 Hz
Delivery system	Fiber deliveryFiber delivery
User interface	Touch screen control	Touch screen control

Table 6: Comparison table of the technical specifications of Fotona SkyPulse Laser Platform with the 1470 nm Diode Laser Module – with previously cleared devices.

	Fox Q-810, Q-980 and Q-1064 Diode Laser(K073322)	neoV980 & neoV1470Diode Lasers(K152722)	Fotona SkyPulse LaserPlatform(this submission)
Energy source	Solid state diode	Solid state diode	Solid state diode
Wavelength	980 nm	1470 nm	1470 nm
Power range	Up to 12 W	Up to 12 W	Up to 22 W
Pulse width	0.1 ms to CW	CW or pulse on: 5-8 s.pulse off: 0.5 s	10 ms - 10 s; CW
Repetition rate	Pulse interval: 0.1 ms -CW	CW or 0.125-0.2 Hz	CW or up to 100 Hz
Delivery system	Fiber delivery	Fiber delivery	Fiber delivery
User interface	Touch screen control	Touch screen control	Touch screen control

Table 7: Comparison table of the technical specifications of Fotona SkyPulse Laser Platform with the 1940 nm Diode Laser Module – with previously cleared device.

	Fox Q-810, Q-980 and Q-1064 Diode Laser(K073322)	Fotona SkyPulse Laser Platform(this submission)
Energy source	Solid state diode	Solid state diode
Wavelength	980 nm	1940 nm
Power range	Up to 12 W	Up to 7.5 W
Pulse width	0.1 ms to CW	CW or 10 ms - 10 s
Repetition rate	Pulse interval: 0.1 ms – CW	CW or up to 100 Hz
Delivery system	Fiber delivery	Fiber delivery
User interface	Touch screen control	Touch screen control

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TESTING

Clinical testing: No clinical testing was needed.

Fotona SkyPulse Laser Platform is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards:

EN 60601-1:2006 + A1:2013 *

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance.

EN 60601-1-2:2015

Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

EN 60601-2-22:2013 **

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.

EN 60601-1-6:2010 + A1:2015 *

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.

EN 62366:2008 + A1:2015 *

Medical devices - Application of usability engineering to medical devices.

EN 60825-1:2014 *

Safety of laser products -- Part 1: Equipment classification and requirements.

EN ISO 14971:2012

Medical devices - Application of risk management to medical devices.

EN 62304:2006 * + A1:2015

Medical device software - Software life-cycle processes.

EN ISO 17664:2004*

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

EN ISO 10993-1:2009#

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

* For international compliance see CB Scheme standards

The standard EN 60601-2-22:2013 and EN 60601-1-2:2015 have been published but not harmonized yet. It is however our decision to follow the current state of the art assuming the newer standards assure a higher level of safety.

A new version of this standard, EN ISO 17664:2017, has been issued. The 36-month transition period is currently in effect. Transition to new standard version is underway (I-6522).

A new version of this standard, EN ISO 10993-1:2018, has been issued. The 36-month transition period is currently in effect. Transition to new standard version is underway (I-7547).

CB Scheme standards:

IEC 60601-1:2005 + A1:2012

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2:2014

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

IEC 60601-2-22:2007 + A1:2012

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.

IEC 60601-1-6:2010 + A1:2013

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.

IEC 60601-1-9:2007 + A1:2013

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral standard: Requirements for environmentally conscious design.

IEC 60825-1:2014

Safety of laser products - Part 1: Equipment classification and requirements.

IEC 62366:2007 + A1:2014

Medical devices - Application of usability engineering to medical devices.

IEC 62304:2006 + A1:2015

Medical device software - Software life-cycle processes.

Laboratory testing was conducted to support that the proposed Fotona SkyPulse Laser Platform meets all design specifications and that meets all design specifications and that it is substantially equivalent to the predicate devices.

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STATEMENT OF SUBSTANTIAL EQUIVALENCE

The Fotona SkyPulse Laser Platform shares the same indications for use, similar design and functional features with predicate devices, and therefore Fotona believes that Fotona SkyPulse Laser Platform is substantially equivalent to the Fotona LightWalker Laser System Family (K191554), Biolase WaterLase Laser System Family (K190319), Fotona Dynamis Pro Laser System Family (K182088), Sciton Joule Multi-Platorform System (K101916), 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 Portable Laser (Oralase) (K082707). Biolase ezlase (K083069). Biolase Epic Pro (K163128) and G.N.S neoLaser neoV980 & neoV1470 Diode Lasers (K152722).

Based on its technical characteristics, performance test data, and its indications for use as listed above, the Fotona SkyPulse Laser Platform is found to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.