· 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 curetage
· 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, 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

Er: Y AG laser (2940 nm wavelength) in dermatology and other surgical areas:
· Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing

· ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia
· Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy
· 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, matrixectomy
· Ophtalmology 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

Nd:YAG laser (1064 nm wavelength) in dentistry:

· Excisional and incisional biopsies
· Excision and vaporization of herpes simplex I and II
· Exposure of unerupted teeth
Fibroma removal
· Frenectomy and frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingivoplasty
Gingival incision and excision
· Hemostasis
· Implant recovery
Incision and drainage of abscess
· Laser assisted uvulopaletoplasty (LAUP)
· Operculectomy
· Oral papillectomies
· Pulpotomy and pulpotomy as an adjunct to root canal therapy
· Reduction of denture hyperplasia
Reduction of gingival hypertrophy
· Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
· Removal of post-surgical granulations
· Soft tissue crown lengthening
· 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)
· Tissue retraction for impression
· Treatment of aphtous ulcers
· Vestibuloplasty
· Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
· Periodontal regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface

Nd: YAG laser (1064 nm wavelength) in dermatology and other surgical areas:
· Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin*
· Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
• Treatment of wrinkles
· Treatment of mild to moderate inflammatory acne vulgaris
· General surgery indications: surgical incision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, 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.)

Nd: YAG laser (1064 nm wavelength) 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.
*Note: Permanent hair reduction is defined as the long-term, stable redction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Device Description

The device is Fotona LightWalker laser system family (same as K191554). It is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamppumped laser sources in one housing, with optical cavities containing the Er.YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er: YAG laser), or, in the case of the Nd: YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.

The Er:YAG laser is capable of delivering up to 1.5 J of laser energy in pulses with durations of 50 - 1000 us and frequencies (repetition rates) of up to 50 Hz. The maximum average output power is 20 W. The laser is intended to be used for incision, cutting, ablation, vaporization and coagulation of soft and hard tissue in dentistry, dermatology and other surgical areas.

The Nd: YAG laser is capable of delivering up to 10 J of energy with pulse durations from 0.1-25 ms, and frequencies of up to 100 Hz. For dental indications it is capable of delivering laser pulses with durations of up to 650 us, frequencies (repetition rates) of up to 100 Hz and a maximum output power of 15 W. The laser is intended to be used for various intra oral treatments in dentistry, and for various surgical and aesthetic applications in dermatology and other surgical areas.

AI/ML Overview

The provided text is a 510(k) Summary for the Fotona LightWalker Laser System Family. This document is related to a medical device (a laser system), not an AI/ML-based device, and therefore the acceptance criteria and study details that would typically apply to an AI/ML device (such as those involving performance metrics like sensitivity, specificity, AUC, and the rigorous ground truth establishment, reader studies, etc., that are characteristic of AI/ML device submissions) are not present in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices by comparing technical specifications and showing compliance with relevant safety and performance standards for laser systems.

Here's why the document does not contain the information requested and what information it does provide:

A table of acceptance criteria and the reported device performance: This sort of table, specifically with quantitative performance metrics (e.g., sensitivity, specificity, accuracy) against pre-defined acceptance thresholds, is characteristic of AI/ML device submissions. For this laser device, the "acceptance criteria" are compliance with established medical device standards (e.g., IEC 60601 series, ISO 14971) and demonstration of equivalent technical specifications to predicate devices. The "reported device performance" is essentially that it meets these standards and functions as intended, and its technical specifications are comparable to cleared devices.
Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the sense of a dataset for evaluating an AI model. The testing refers to engineering and compliance testing (e.g., electrical safety, EMC, laser safety standards), not performance evaluation on a patient dataset. The document explicitly states: "Clinical testing: No clinical testing was needed."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of AI/ML refers to validated labels for a dataset, typically established by expert readers or pathology. For a laser device, there's no such "ground truth" to establish for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no test set or human interpretation involved in the performance evaluation described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a study design specific to evaluating the clinical impact of AI assistance on human readers. The device is a laser system, not an AI software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm to evaluate in a standalone manner.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as explained above.
The sample size for the training set: Not applicable. There is no AI model that requires a training set.
How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "acceptance criteria" and "study":

Acceptance Criteria (Implicit through comparison and standards compliance):

Identical or similar technological and design characteristics to legally marketed predicate devices (Fotona LightWalker Laser System Family (K191554), Biolase WaterLase Laser System Family (K190319), Fotona Dynamis Pro Laser System Family (K182088)).
Similar output characteristics to predicate devices for the proposed intended use.
Compliance with applicable mandatory and voluntary standards, including:
- EN 60601-1 (Medical electrical equipment – General requirements for basic safety and essential performance)
- EN 60601-1-2 (Electromagnetic compatibility)
- EN 60601-2-22 (Particular requirements for surgical, cosmetic, therapeutic and diagnostic laser equipment)
- EN 60601-1-6 (Usability)
- EN 62366 (Usability engineering)
- EN 60825-1 (Safety of laser products)
- EN ISO 14971 (Risk management)
- EN 62304 (Medical device software)
- EN ISO 17664 (Sterilization information)
- EN ISO 10993-1 (Biological evaluation)
- Corresponding IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 62304, IEC 62366).

Device Performance (as reported within the context of the 510(k) submission):

The device performance is demonstrated by its technical specifications being comparable to predicate devices and by its compliance with relevant safety and performance standards.

Table: Comparison of Technical Specifications (from the document)

Characteristic	LightWalker Laser System Family (K191554)	WaterLase Laser System Family (K190319)	Dynamis Pro Laser System Family (K182088)	LightWalker Laser System Family (this submission)
Energy source	Solid state Er:YAG	Solid state Er,Cr:YSGG	Solid state Er:YAG	Solid state Er:YAG
Wavelength	2940 nm	2780 nm	2940 nm	2940 nm
Aiming beam	Laser diode 635nm/650nm (red) or 520-532nm (green); < 1 mW	Laser diode 635 nm (red); < 1 mW	Laser diode 635nm/650nm (red); < 1 mW	Laser diode 635nm/650nm (red) or 520-532nm (green); < 1 mW
Power	Up to 20 W	Up to 10 W	Up to 20 W	Up to 20 W
Energy per pulse	Up to 1500 mJ	Up to 600 mJ	Up to 3000 mJ	Up to 1500 mJ
Pulse width	50-1000 us	60-700 us	50-1500 us	50-1000 us
Repetition rate	Up to 50 Hz	Up to 100 Hz	Up to 50 Hz	Up to 50 Hz
Delivery system	Articulated arm	Fiber delivery	Articulated arm	Articulated arm
User interface	Touch screen control	Touch screen control	Touch screen control	Touch screen control

The "Study" Proving Acceptance:

The "study" or testing conducted to prove the device meets acceptance criteria primarily involved laboratory testing to ensure:

The device meets all design specifications.
The device complies with the aforementioned national and international safety, performance, and quality management standards for medical electrical equipment and laser products.
The device's technical characteristics and intended use are substantially equivalent to the predicate devices.

The document explicitly states: "No clinical testing was needed." This means the demonstration of substantial equivalence and safety/effectiveness was achieved through non-clinical means, primarily engineering tests and comparisons to existing cleared devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

March 25, 2020

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

Re: K193661

Trade/Device Name: LightWalker Laser System Family 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

{1}------------------------------------------------

statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 post-marketing 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 (QS) 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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193661

Device Name LightWalker Laser System Family

Indications for Use (Describe) Er: YAG laser (2940 nm wavelength) 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 curetage
· 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, 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

{3}------------------------------------------------

Er: Y AG laser (2940 nm wavelength) in dermatology and other surgical areas:

· Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing

· ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia
· Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy

· 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, matrixectomy
· Ophtalmology 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

Nd:YAG laser (1064 nm wavelength) in dentistry:

· Excisional and incisional biopsies
· Excision and vaporization of herpes simplex I and II
· Exposure of unerupted teeth
Fibroma removal
· Frenectomy and frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingivoplasty
Gingival incision and excision
· Hemostasis
· Implant recovery
Incision and drainage of abscess
· Laser assisted uvulopaletoplasty (LAUP)
· Operculectomy
· Oral papillectomies
· Pulpotomy and pulpotomy as an adjunct to root canal therapy
· Reduction of denture hyperplasia
Reduction of gingival hypertrophy
· Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
· Removal of post-surgical granulations
· Soft tissue crown lengthening

· 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)

· Tissue retraction for impression
· Treatment of aphtous ulcers
· Vestibuloplasty

· Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)

· Periodontal regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface

{4}------------------------------------------------

Nd: YAG laser (1064 nm wavelength) in dermatology and other surgical areas:

· Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin*

· Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins

• Treatment of wrinkles

· Treatment of mild to moderate inflammatory acne vulgaris

· General surgery indications: surgical incision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, 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.)

Nd: YAG laser (1064 nm wavelength) 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.

*Note: Permanent hair reduction is defined as the long-term, stable redction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 24, 2020

DEVICE INFORMATION

Device Trade Name:	LightWalker Laser System Family
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 Laser System Family (K190319)
Fotona Dynamis Pro Laser System Family (K182088) •

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DEVICE DESCRIPTION

INTENDED USE

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 ー
-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 curetage
-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) ー
-Root-end preparation for retrofill amalgam or composite
-Full thickness flap
-Partial thickness flap
Split thickness flap ー
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 pocket lining junctional epithelium

510(k) Submission: Fotona LightWalker Laser System Family

{7}------------------------------------------------

K193661

-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 —

2940 nm Er: YAG Laser in dermatology and other surgical areas

Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing
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, matrixectomy -
-Ophtalmology 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

Nd:YAG laser (1064 nm wavelength) in dentistry:

Excisional and incisional biopsies -
Excision and vaporization of herpes simplex I and II -
Exposure of unerupted teeth -
Fibroma removal -
-Frenectomy and frenotomy
-Gingival troughing for crown impressions
Gingivectomy
-Gingivoplasty
-Gingival incision and excision
-Hemostasis
Implant recovery -
-Incision and drainage of abscess
-Laser assisted uvulopaletoplasty (LAUP)
-Operculectomy
-Oral papillectomies
Pulpotomy and pulpotomy as an adjunct to root canal therapy -
Reduction of denture hyperplasia -
-Reduction of gingival hypertrophy

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

K193661

Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
Removal of post-surgical granulations —
-Soft tissue crown lengthening
-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)
-Tissue retraction for impression
Treatment of aphtous ulcers —
Vestibuloplasty —
-Laser assisted new attachment procedure (cementum-mediated periodontal ligament newattachment to the root surface in the absence of long junctional epithelium)
-Periodontal regeneration - true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface

Nd:YAG laser (1064 nm wavelength) in dermatology and other surgical areas:

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin*
Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
-Treatment of wrinkles
Treatment of mild to moderate inflammatory acne vulgaris —
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.)

Nd:YAG laser (1064 nm wavelength) 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.
*Note: Permanent hair reduction is defined as the long-term, stable redction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The Fotona LightWalker Laser System Family 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 Er:YAG/Nd:YAG Laser System Family (K191554), Biolase WaterLase Laser System Family (K190319) and Fotona Dynamis Pro Laser System Family (K182088). The output characteristics of the proposed device are similar to those of the predicate devices for the proposed intended use. All of the devices utilize class I aiming beams that pose a minimal hazard to the user when the devices are used properly. 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.

A comparison of the technical specifications for the intended use of the LightWalker Laser System Family with the previously cleared devices is provided in Table 1.

	LightWalkerLaser SystemFamily(K191554)	WaterLase LaserSystem Family(K190319)	Dynamis Pro LaserSystem Family(K182088)	LightWalker LaserSystem Family(this submission)
Energy source	Solid state Er:YAG	Solid stateEr,Cr:YSGG	Solid state Er:YAG	Solid state Er:YAG
Wavelength	2940 nm	2780 nm	2940 nm	2940 nm
Aiming beam	Laser diode 635nm/650 nm (red) or520-532 nm (green); < 1 mW	Laser diode 635 nm(red) ; < 1 mW	Laser diode 635nm/650 nm (red) ; < 1mW	Laser diode 635nm/650 nm (red) or520-532 nm (green);< 1 mW
Power	Up to 20 W	Up to 10 W	Up to 20 W	Up to 20 W
Energy per pulse	Up to 1500 mJ	Up to 600 mJ	Up to 3000 mJ	Up to 1500 mJ
Pulse width	50-1000 us	60-700 us	50-1500 us	50-1000 us
Repetition rate	Up to 50 Hz	Up to 100 Hz	Up to 50 Hz	Up to 50 Hz
Delivery system	Articulated arm	Fiber delivery	Articulated arm	Articulated arm
User interface	Touch screencontrol	Touch screencontrol	Touch screencontrol	Touch screencontrol

Table 1: Comparison table of the technical specifications of Fotona LightWalker Laser System Family with previously cleared devices.

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TESTING

Clinical testing:

No clinical testing was needed.

Fotona LightWalker laser system family 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

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 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 LightWalker laser system family meets all design specifications and that it is substantially equivalent to the predicate devices.

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STATEMENT OF SUBSTANTIAL EQUIVALENCE

The LightWalker Laser System Family shares the same indications for use, similar design and functional features with predicate devices, and therefore Fotona believes that its LightWalker laser system family is substantially equivalent to the Fotona LightWalker Er:YAG/Nd:YAG Laser System Family (K191554), Biolase WaterLase Laser System Family (K190319) and Fotona Dynamis Pro Laser System Family (K182088).

Based on its technical characteristics, performance test data, and its indications for use as listed above, the Fotona LightWalker Laser System 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.