(28 days)
Not Found
No
The summary describes a laser system for surgical procedures and therapy, focusing on the laser technology and its applications. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described with numerous "Intended Use / Indications for Use" that involve treating a wide range of medical conditions, illnesses, and injuries across various anatomical sites and medical specialties, including pain relief, which are characteristics of a therapeutic device.
No
The device is described as a laser system used for various surgical procedures, including incision, excision, ablation, coagulation, and removal of tissues. It is a therapeutic device, not one designed to identify or diagnose conditions.
No
The device description clearly states it is a laser system with physical components (laser sources, housing, articulated arm, handpieces, optical fiber). This is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Fotona LightWalker Laser System Family is a therapeutic device that uses laser energy to directly interact with and modify tissues (cutting, ablating, coagulating, etc.). It is used for surgical procedures and treatments on the body.
- Intended Use: The extensive list of intended uses clearly describes surgical and therapeutic applications on various parts of the body, not the analysis of specimens outside the body.
The device's function and intended uses are consistent with a surgical laser, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 curettage;
- · Laser removal of porcelain and ceramic crowns and veneers;
- · Flap preparation incision of soft-tissue to prepare a flap and expose the bone;
- · Cutting bone to prepare a window access to the apex (apices) of the root(s);
- · Root-end preparation for retrofill amalgam or composite;
- · Full thickness flap;
- · Partial thickness flap;
- · Split thickness flap;
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket;
- · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket Iming 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:
The LightWalker Er: YAG laser is intended for surgical incision, cutting, ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
· Dermatology and Plastic Surgery Indications: epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing;
· ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
· Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy;
-
Uvulopalatoplasty by laser resurfacing
· 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;
-
· Dermatological procedures requiring resurfacing of soft tissue with Fotona FS-01 fractionated handpiece.
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 toothmobility);
- · Tissue retraction for impression;
- Treatment of aphtous ulcers;
- · Vestibuloplasty;
· Laser assisted new attachment procedure (cementum-mediated periodontal ligament no 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, 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.);
· Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicosities.
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.
Product codes
GEX
Device Description
The Fotona LightWalker Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra-oral soft tissue, Pulp, Teeth, Oral osseous tissue (bone), Periodontal pockets, Skin, Cutaneous tissue, Subcutaneous tissue, Striated and smooth tissue, Muscle, Cartilage meniscus, Mucous membrane, Lymph vessels and nodes, Organs, Glands, Epidermal nevi, Actinic cheilitis, Verrucae, Skin tags, Keratoses, ENT lesions, Cysts, Polyps, Hyperkeratosis, Oral leukoplakia, Oral and glossal lesions, Gingiva, Uvulopalatoplasty, Warts, Plantar verrucae, Leg veins, Spider veins, Soft tissue surrounding the eye, External genitalia, Urethra, Anus, Penis, Scrotum, Vulvar lesions, Colon, Unwanted hair, Pigmented and vascular lesions (port wine stains, hemangiomae, telangiectasiae, rosacea, venus lake), Wrinkles, Onychomycosis, Superficial incompetent tributary veins, Muscles, Joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted on the subject device, and it was established that the newly introduced features do not raise different questions of safety or effectiveness.
Clinical testing was not considered to be needed for this pre-market notification. The submitted LightWalker Laser System Family's indications for use and technological characteristics do not raise new types of questions regarding safety and efficacy when compared to predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2024
Fotona d.o.o. Tina Bartolic Quality Assurance and Regulatory Affairs Specialist Stegne 7 Ljubljana, Slovenia
Re: K242202
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: July 26, 2024 Received: July 26, 2024
Dear Tina Bartolic:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
TANISHA by TANISHA L HITHE -S L. HITHE -S o 11:27:11 -04'00'
Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K242202
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 curettage;
- · Laser removal of porcelain and ceramic crowns and veneers;
- · Flap preparation incision of soft-tissue to prepare a flap and expose the bone;
- · Cutting bone to prepare a window access to the apex (apices) of the root(s);
- · Root-end preparation for retrofill amalgam or composite;
- · Full thickness flap;
- · Partial thickness flap;
- · Split thickness flap;
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket;
- · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket Iming 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:
The LightWalker Er: YAG laser is intended for surgical incision, cutting, ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
· Dermatology and Plastic Surgery Indications: epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing;
· ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
4
· Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy;
-
Uvulopalatoplasty by laser resurfacing
· 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;
-
· Dermatological procedures requiring resurfacing of soft tissue with Fotona FS-01 fractionated handpiece.
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 toothmobility);
- · Tissue retraction for impression;
- Treatment of aphtous ulcers;
- · Vestibuloplasty;
· Laser assisted new attachment procedure (cementum-mediated periodontal ligament no 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;
5
· General surgery indications: surgical incision, 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, 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.);
· Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicosities.
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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6
Image /page/6/Picture/2 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, light gray font. There is a red dot above the "a" in "Fotona".
Fotona
Stegne 7, 1000 Ljubljana, Slovenia
t. +386 (0)1 500 91 00
f. +386 (0)1 500 92 00
www.fotona.com
Image /page/6/Picture/4 description: The image contains several logos and text elements. At the top, there is a gray octagon containing the text "TUV PRODUCT SERVICE" along with "ISO 9001" and "ISO 13485". Below this, the text "founding member" is displayed above the "FOTONIKA 21" logo. The words "competency center" and "biomedical engineering" are on either side of a gray cube-like logo.
SPECIAL 510(K) SUMMARY
| 1. SUBMITTER INFORMATION | |
|---|---|
| Applicant & OfficialCorrespondent | Ms. Tina Bartolic |
| Quality Assurance and Regulatory Affairs Specialist | |
| Fotona d.o.o. | |
| Stegne 7, Ljubljana, Slovenia | |
| +38615009100 | |
| tina.bartolic@fotona.com | |
| Date Prepared | August 12, 2024 |
| 2. DEVICE NAME | |
| Trade Name of the Device | LightWalker Laser System Family |
| Common Name: | LightWalker Laser System Family |
| Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Classification Regulation: | 21 CFR 878.4810 |
| Device Class: | Class II |
| Product Code: | GEX |
| Panel: | General and Plastic Surgery |
| 3. PREDICATE DEVICEIDENTIFICATION | K202985 LightWalker Laser System Family |
| 4. DEVICE DESCRIPTION: | The Fotona LightWalker Laser System Family is |
| based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) | |
| laser technology. It combines two flashlamp-pumped | |
| 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. | |
| 5. INDICATIONS FOR USE: | 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, root | |
| canal debridement and cleaning, root canal preparation | |
| including enlargement; |
7
Image /page/7/Picture/2 description: The image shows the logo for Fotona, a company that specializes in laser technology. The word "Fotona" is written in a bold, sans-serif font, with the "o" in "Fotona" having a red dot above it. Below the word "Fotona" is the tagline "choose perfection" in a smaller, gray font.
Fotona
Stegne 7, 1000 Liubliana, Slove 86 (0)1 500 91 00 386 (0)1 500 92 00 ww.totona.com
Image /page/7/Picture/5 description: The image shows a collection of logos and text. At the top is a gray octagon containing the text "TUV PRODUCT SERVICE" and "ISO 9001" and "ISO 13485". Below that is the text "founding member:" and the FOTONIKA 21 logo. At the bottom are the words "competency center" and "biomedical engineering".
· 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 amalgam or composite:
- · Full thickness flap;
- Partial thickness flap;
- · Split thickness flap;
- Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket;
· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining
-
junctional epithelium; · Excisional and incisional biopsies;
· Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions); -
Frenectomy and frenotomy;
-
· Gingival troughing for crown impressions;
-
· Gingivectomy;
-
· Gingivoplasty;
-
· Implant recovery;
-
· Root canal debridement and cleaning;
-
· Soft tissue crown lengthening;
· Laser root canal disinfection after endodontic treatment;
Er: YAG laser (2940 nm wavelength) in dermatology and other surgical areas:
The LightWalker Er:YAG laser is intended for surgical incision/excision, cutting, ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
· Dermatology and Plastic Surgery Indications: epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing;
8
Image /page/8/Picture/2 description: The image shows the logo for Fotona. The word "Fotona" is written in a bold, sans-serif font, with the letters in a dark gray color. Above the "o" in Fotona is a red circle. Below the word "Fotona" is the phrase "choose perfection" in a smaller, light gray font.
Fotona
ne 7. 1000 Liubliana, Slove 86 (0)1 500 91 00 386 (0)1 500 92 00 w.totona.com
Image /page/8/Picture/5 description: The image shows two logos. The first logo is an octagon with the letters "TUV" inside of it. The words "PRODUCT SERVICE" are written below the letters. The words "ISO 9001" and "ISO 13485" are written on the left and right sides of the octagon, respectively. The second logo is for "FOTONIKA 21" and includes the words "competency center" and "biomedical engineering".
· ENT Surgery Indications: ENT lesions, cysts, polyps. hyperkeratosis, oral leukoplakia;
· Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy;
· Uvulopalatoplasty by laser resurfacing
· 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;
· Dermatological procedures requiring resurfacing of soft tissue with Fotona FS-01 fractionated handpiece.
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;
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Image /page/9/Picture/2 description: The image shows the logo for Fotona, a company that specializes in laser technology. The logo features the word "Fotona" in a gray, sans-serif font. Above the "a" in Fotona is a red circle. Below the word "Fotona" is the tagline "choose perfection" in a smaller, gray, sans-serif font.
Fotona
Stegne 7, 1000 Liubliana, Slover +386 (0)1 500 91 00 +386 (0)1 500 92 00 ww.fotona.com
Image /page/9/Picture/5 description: The image shows a logo with the text "TUV PRODUCT SERVICE" inside an octagon shape. The text "ISO 9001" is on the left side of the octagon, and the text "ISO 13485" is on the right side. Below the octagon, the text "founding member" is present above the word "FOTONIKA 21". The words "competency center" and "biomedical engineering" are at the bottom of the image.
• 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 toothmobility); · Tissue retraction for impression; · Treatment of aphtous ulcers; · Vestibuloplasty; · Laser assisted new attachment procedure (cementummediated periodontal ligament new-attachment 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.); · Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.
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Image /page/10/Picture/1 description: The image shows the logo for Optona. The logo consists of the word "otona" in a dark gray, serif font. To the right of the word, there is a red circle. The circle is slightly above the top of the letters in the word.
choose perfection
Fotona
Stegne 7, 1000 Liubliana, Slovenia 86 (0)1 500 91 00 -386 (0)1 500 92 00 www.fotona.com
Image /page/10/Picture/5 description: The image shows a logo with the text "TUV PRODUCT SERVICE" inside an octagon shape. The text "ISO 9001" and "ISO 13485" are on the left and right sides of the octagon, respectively. Below the logo, the text "founding member:" is displayed above the word "FOTONIKA 21" with three circles to the left. The words "competency center" and "biomedical engineering" are on either side of a cube shape.
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.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| | LightWalker Laser System Family
(K202985) | | LightWalker Laser System Family
(K242202- this submission) | |
|----------------------------------|----------------------------------------------|-------------------------------------|---------------------------------------------------------------|-------------------------------------|
| | Er:YAG | Nd:YAG | Er:YAG | Nd:YAG |
| Wavelength | 2940 nm | 1064 nm | 2940 nm | 1064 nm |
| Laser media | Flashlamp solid
state Er:YAG rod | Flashlamp solid state
Nd:YAG rod | Flashlamp solid state
Er:YAG rod | Flashlamp solid state
Nd:YAG rod |
| Output mode | Pulsed | Pulsed | Pulsed | Pulsed |
| Pulse energy | Up to 1.5 J | Up to 20 J | Up to 1.5 J | Up to 20 J |
| Pulsewidth | 0.025 – 1 ms | 0.1 - 25 ms | 0.025 - 1 ms | 0.1 - 25 ms |
| Repetition
rate | Up to 50 Hz | Up to 100 Hz | Up to 50 Hz | Up to 100 Hz |
| Power | Up to 20 W | Up to 30 W | Up to 20 W | Up to 30 W |
| Beam
Delivery | Articulated Arm | Fiber | Articulated Arm | Fiber |
| User
Interface | Touchscreen | Touchscreen | Touchscreen | Touchscreen |
| Operating
System | Windows | Windows | Linux | Linux |
| User
Interface
Screen Size | 8.4" | 8.4" | 10.1" | 10.1" |
The subject and the predicate device have the same intended use, and have the same technological characteristics in terms of laser output parameters, as can be concluded from the above comparison table. Both devices use the same housing, laser sources, power supplies, cooling system and beam delivery system, the only difference being in the type of the operating system and in the size of the user interface screen. Based on its technical characteristics, design, functional features, performance test data, and its indications for use, the
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Image /page/11/Picture/2 description: The image shows the logo for Fotona, a company that specializes in laser technology. The word "Fotona" is written in a simple, sans-serif font in gray color. Below the word "Fotona" is the tagline "choose perfection" in a smaller, lighter gray font. To the right of the word "Fotona" is a red circle, which serves as a visual element in the logo.
Fotona Stegne 7, 1000 Ljubljana, Slovenia t. +386 (0)1 500 91 00 f. +386 (0)1 500 92 00 www.fotona.com
Image /page/11/Picture/4 description: The image contains several logos and text elements. At the top, there is a gray octagon containing the "TUV PRODUCT SERVICE" logo, along with "ISO 9001" and "ISO 13485" labels. Below this, the text "founding member:" is displayed above the "FOTONIKA 21" logo. At the bottom, the words "competency center" and "biomedical engineering" are written on either side of a gray cube.
submitted device is considered to be substantially equivalent to the predicate device. Performance testing was conducted on the subject device, and it was established that the newly introduced features do not raise different questions of safety or effectiveness
| 7.SUMMARY OF NONCLINICAL TESTING: | Below is a list of the tests that were performed and
successfully completed for the subject device per the
specified guidance and standards. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Performance standards |
| | IEC 60601-1:2005 + A1:2012 + A2:2020
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance. |
| | IEC 60601-1-2:2014 + A1:2020
Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests. |
| | IEC TR 60601-4-2:2016
Medical electrical equipment – Part 4-2: Guidance and
interpretation - Electromagnetic immunity:
performance of medical electrical equipment and
medical electrical systems |
| | IEC 60601-2-22:2019
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 + A2:2020
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 |
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K242202
Image /page/12/Picture/2 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, light gray sans-serif font. To the right of the word "Fotona" is a red circle.
- CONCLUSIONS
ne 7, 1000 Ljubljana, Sloven 86 (0)1 500 91 00 86 (0)1 500 92 00 w.fotona.com
Image /page/12/Picture/5 description: The image shows a logo with the text "TUV PRODUCT SERVICE" inside of a polygon shape. Above the polygon shape is a recycling symbol. The text "ISO 9001" is on the left side of the polygon, and the text "ISO 13485" is on the right side. Below the logo, the text "founding member: DOOFOTONIKA 21" is present.
Medical devices - Application of usability engineering to medical devices. IEC 62366-1:2015 Medical devices - Application of usability engineering to medical devices. IEC 62304:2006 + A1:2015 Medical device software - Software life-cycle processes ISO standards ISO 14971:2019 Medical devices - Application of risk management to medical devices ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices -Part 2: Non-critical medical devices ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Specified guidance · Software Verification and Validation Testing according to FDA's Guidance (2023), "Content of Premarket Submissions for Device Software Functions | FDA" · Cybersecurity testing according to FDA Guidance document (2023), "Cybersecurity in MedicalDevices: Quality System Considerations and Content of Premarket Submissions | FDA". 8.SUMMARY OF CLINICAL TESTING: Clinical testing was not considered to be needed for this pre-market notification. The submitted LightWalker Laser System Family's indications for use and technological
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K242202
Image /page/13/Picture/8 description: The image is a blank white canvas. There are no objects or figures present. The image is completely devoid of any content.
Image /page/13/Picture/2 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, lighter gray font. To the right of the word "Fotona" is a red circle.
Fotona
Stegne 7, 1000 Ljubljana, Slovenia t. +386 (0)1 500 91 00 f. +386 (0)1 500 92 00 www.fotona.com
Image /page/13/Picture/5 description: The image contains several logos and text elements. At the top, there is a gray octagon containing the text "TUV PRODUCT SERVICE" and the certifications "ISO 9001" and "ISO 13485". Below this, the text "founding member" is displayed above the "FOTONIKA 21" logo, which consists of three circles and the text "FOTONIKA 21". At the bottom, the text "competency center" is on the left, and "biomedical engineering" is on the right, flanking a cube-like logo in the center.
characteristics do not raise new types of questions regarding safety and efficacy when compared to predicate. Based on its technical characteristics, design, functional features, performance test data, and its indications for use, the Fotona LightWalker Laser System Family (K242202) is considered to be substantially equivalent to the predicate device (K202985).