(170 days)
Not Found
No
The summary describes a laser system with various applications but does not mention any AI or ML components in its intended use, device description, or performance studies.
Yes
The device specifically lists "Nd:YAG laser (1064 nm wavelength) therapy," with indications such as "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." These uses directly align with the definition of a therapeutic device designed to treat or alleviate health conditions.
No
The device description and intended uses primarily focus on surgical and therapeutic applications such as incision, excision, ablation, coagulation, and various treatments, rather than diagnosis.
No
The device description clearly states it is a laser system with physical components (laser sources, housing, articulated arm, handpieces, optical fiber delivery system). It is a hardware device that utilizes laser technology for various surgical and aesthetic procedures.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended uses listed for the Fotona LightWalker Laser System Family involve direct interaction with and treatment of tissues within the body (intra-oral, skin, organs, etc.). They are surgical and therapeutic procedures.
- The device description details a laser system for cutting, ablating, vaporizing, and coagulating tissue. This is a description of a surgical tool, not a device used for analyzing biological samples.
- The performance studies mentioned are verification and validation tests for conformance to regulations and safety standards. This is typical for surgical devices, not IVDs which would focus on analytical and clinical performance related to diagnostic accuracy.
The intended uses clearly describe a device used for surgical and therapeutic interventions on living tissue, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Er: Y A G 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 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:
The LightWalker Er: YAG laser is intended for surgical incision/excision, 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, valvar 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 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, 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.);
· 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.
The Fotona LightWalker Laser System Family and its accessories will be marketed for the following indications:
Er:YAG laser (2940 nm wavelength) in dentistry:
- -Intra-oral soft tissue surgery (incision, excision, ablation, coagulation);
- -Leukonlakia:
- 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 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, 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/excision and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection 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 uvulopalatoplasty (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;
- ー 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 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, vaporization and coagulation of soft tissue. All soft tissue ー is included, striated and smooth tissue, muscle, cartillage, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal;
- -Podiaty (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 ー mentagrophytes and/or yeasts Candida albicans, etc.);
- -Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and 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 (comma separated list FDA assigned to the subject device)
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. The Er:YAG laser is intended to be used for incision/excision, cutting, ablation, vaporization and coagulation of soft and hard tissue in dentistry, dermatology and other surgical areas. The Nd:YAG 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra-oral, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, glands, ENT lesions, oral, glossal lesions, eye, external genitalia, urethra, anus, penis, scrotum, vulva, colon, 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)
The LightWalker Laser System Family has been evaluated via verification and validation tests and inspections for conformance to the applicable regulations and safety standards. The LightWalker Laser System is designed, tested and will be manufactured in accordance with both, mandatory and voluntary standards: EN 60601-1:2006 + A1:2013, EN 60601-1-2:2015, EN 60601-2-22:2013, EN 60601-1-6:2010 + A1:2015, EN 62366:2008 + A1:2015, EN 60825-1:2014, EN ISO 14971:2012, EN 62304:2006 + A1:2015, EN ISO 17664:2017, EN ISO 10993-1:2009. For international compliance: IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014, IEC 60601-2-22:2007 + A1:2012, IEC 60601-1-6:2010 + A1:2013, IEC 60601-1-9:2007 + A1:2013, IEC 60825-1:2014, IEC 62366:2007 + A1:2014, IEC 62304:2006 + A1:2015, ISO 14971:2007, ISO 17664:2004, ISO 17664:2017, ISO 10993-1:2009, ISO 10993-1:2018.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 19, 2021
Fotona d.o.o. Pucer Anja Quality Assurance and Regulatory Affairs Stegne 7 Ljubljana. SI-1000 Slovenia
Re: K202985
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: September 30, 2020 Received: September 30, 2020
Dear Pucer Anja:
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.
1
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 and Part 809: 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,
Purva Pandya 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
2
Indications for Use
510(k) Number (if known) K202985
Device Name
LightWalker Laser System Family
Indications for Use (Describe)
Er: Y A G 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 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:
The LightWalker Er: YAG laser is intended for surgical incision/excision, 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;
3
· 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, valvar 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 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
4
included, striated and smooth tissue, muscle, cartillage, 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.);
· 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)
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 7 | |||||
| 1000 Ljubljana, Slovenia | |||||
| Phone: +386 1 5009 100 | |||||
| Fax: +386 1 5009 200 | |||||
| Contact Person: | Dr. Pucer Anja | ||||
| Phone: +386 1 5009 100 | |||||
| E-mail: anja.pucer@fotona.com | |||||
| Date: | February 18, 2021 |
DEVICE INFORMATION
| Device Trade Name: | LightWalker Laser System Family |
|---|---|
| Common name: | Medical Laser System |
| Classification name: | GEX-Powered Laser Surgical Instrument, General and Plastic Surgery |
| 21 CFR 878.4810, Class II | |
| Product Code: | GEX |
PREDICATE DEVICES
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DEVICE DESCRIPTION SUMMARY
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. The Er:YAG laser is intended to be used for incision/excision, cutting, ablation, vaporization and coagulation of soft and hard tissue in dentistry, dermatology and other surgical areas. The Nd:YAG 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.
INTENDED USE/INDICATIONS FOR USE
The Fotona LightWalker Laser System Family and its accessories will be marketed for the following indications:
Er:YAG laser (2940 nm wavelength) in dentistry:
- -Intra-oral soft tissue surgery (incision, excision, ablation, coagulation);
- -Leukonlakia:
- 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 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;
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K202985
Er: YAG 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/excision and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection 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 uvulopalatoplasty (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;
- ー 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 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.
510(k) Submission: Fotona LightWalker Laser System Family
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K202985
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 ー is included, striated and smooth tissue, muscle, cartillage, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal;
- -Podiaty (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 ー mentagrophytes and/or yeasts Candida albicans, etc.);
- -Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and
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.
INDICATIONS FOR USE COMPARISON
The indications for use from the predicate laser devices that are now included in the LightWalker Laser System Family do not raise new types of questions regarding safety and effectiveness. A new Uvulopalatoplasty by laser resurfacing indication for use with the Er.YAG laser output (2940 nm) has been introduced, based on the Laser assisted uvulopalatoplasty indication for use previously cleared for the primary predicate device with the Nd:YAG laser output (1064 nm).
TECHNOLOGICAL COMPARISON
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 Laser System Family (K193661) and Dynamis Pro Family (K182088). Four new handpieces have been introduced. The new handpieces offer new treatment options for specific indications for use that were previously cleared for the predicate devices. 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.
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| | LightWalker Laser
System Familv
(K193661) | | Dynamis Pro Family
(K182088) | | LightWalker Laser System Family
(K202985) | |
|---------------------|-------------------------------------------------------------------|-----------------------|---------------------------------|------------------------|------------------------------------------------------------------|--------------------|
| Energy
source | Solid state
Er:YAG | Solid state
Nd:YAG | Solid state
Er:YAG | Solid state
Nd: YAG | Solid state Er:YAG | Solid state Nd:YAG |
| Wavelength | 2940 nm | 1064 nm | 2940 nm | 1064 nm | 2940 nm | 1064 nm |
| Aiming
beam | Laser diode 635 nm/650 nm
(red) or 520-532 nm (green);
l mW | | 650 nm (red) ;