(79 days)
No
The document describes a laser system with various surgical and therapeutic applications. There is no mention of AI or ML in the intended use, device description, or any other section. The device's functionality is based on laser technology and its physical effects on tissue.
Yes.
The Nd:YAG laser (1064 nm wavelength) therapy section explicitly states indications for "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," which are therapeutic applications. Additionally, one of its predicate devices, K141861, is named "Hilthera 4.0 Therapeutical Laser System."
No
The provided text lists various therapeutic and surgical applications for the laser system (e.g., incision, excision, ablation, removal, treatment), but no indications for diagnosing conditions.
No
The device description clearly states it is a laser system with physical components (laser sources, articulated arm, handpieces, fiber delivery system). It is a hardware device that utilizes laser technology for various medical procedures.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a laser system used for surgical procedures (incision, excision, ablation, coagulation, cutting, etc.) on various tissues (soft tissue, hard tissue, bone, skin, etc.) within and on the human body.
- Intended Use: The intended uses listed are all direct treatments or procedures performed on a patient's body, not on specimens taken from the body.
The device is a therapeutic laser system used for surgical and therapeutic applications, which falls under the category of medical devices, but not specifically 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 curetage
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
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 - 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, 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 stiffhess, arthritis pain or muscle spassn. temporary increase in local blood circulation and/or promoting relaxation of muscle.
Product codes
GEX
Device Description
The device is Fotona LightWalker laser system family (same as K172819). It 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 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/excision, 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 0.5 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 intraoral treatments in dentistry, for various surgical and aesthetic applications in dermatology and other surgical areas, and for pain reduction indication stated below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra-oral, soft tissue (skin, ENT lesions, oral/maxillofacial lesions, general surgery soft tissue including striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma, podiatry soft tissue, soft tissue surrounding the eye, cervical, endometrial), muscle, joint, nails, hair, pigmented and vascular lesions.
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)
Not Found
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 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 contains 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.
October 15, 2019
Fotona d.o.o. Lina Rupnik R&D Quality Department Stegne 7 Ljubljana, 1000 Si
Re: K191554
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: June 7, 2019 Received: June 12, 2019
Dear Lina Rupnik:
This letter corrects our substantially equivalent letter of August 30, 2019.
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/cfpmr/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); 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 (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 U. Pandya -S
Purva Pandva Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191554
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 curetage
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
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)
3
- · 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 - 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, 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 stiffhess, arthritis pain or muscle spassn. temporary increase in local blood circulation and/or promoting relaxation of muscle.
*Note: Permanent hair reduction is defined as the long-term, stable reduction 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
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: | Lina Rupnik, R&D Quality Department
Phone: +386 1 5009 314
E-mail: lina.rupnik@fotona.com |
| Date: | August 21, 2019 |
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
DEVICE DESCRIPTION
The device is Fotona LightWalker laser system family (same as K172819). It 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 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
6
K191554
W. The 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 capable of delivering up to 0.5 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 intraoral treatments in dentistry, for various surgical and aesthetic applications in dermatology and other surgical areas, and for pain reduction indication stated below.
INTENDED USE
a) The Fotona LightWalker Laser System Family and its accessories will be marketed for the following indication added in this submission:
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.
b) Fotona LightWalker Laser System Family and its accessories will also be marketed for the following indications for use, already previously cleared under K172819:
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
Er: YAG 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/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;
7
K191554
- 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;
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
- Gingivoplastv .
- 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 - 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, excision, and coagulation of soft tissue) including: .
8
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.).
*Note: Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The Fotona LightWalker Laser System Family has the same 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's LightWalker Laser System family Device (K172819) and the second predicate device Hilthera 4.0 Therapeutical Laser System (K141861). The output characteristics are for the intended use the same as those of the predicate devices. All lasers utilize Class II aiming beams which pose no hazard to the user. All systems are microprocessor controlled devices. The microprocessor control regulates normal operation, permits parameter selection and avoids hazard incidence. All systems utilize an internal closed loop water-air heat exchanger circuit for optimal thermal control of the risk and benefits for the Fotona LightWalker Laser System Family are identical to the predicate devices when used for similar clinical applications.
The indications for use required no changes to the device or software previously cleared to market, thus we believe LightWalker Laser System Family is substantially equivalent in terms of indications for use and technology based on technical characteristics to previously predicate devices.
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 below.
9
K191554
Table 1 : Comparison table of the technical specifications for Er:YAG and Nd:YAG laser of Fotona LightWalker Laser System Family, the primary predicate LightWalker Laser System Family (K172819) and the secondary predicate Hilthera 4.0 Therapeutical Laser System (K141861), which is the predicate for the newly submitted indication for use.
| | Fotona
LightWalker Family | | Jeysis Medical, Inc.
Hilthera 4.0 | Fotona
LightWalker Family | |
|----------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K172819 | | K141861 | K191554 | |
| Energy source | Er:YAG laser | Nd:YAG laser | Nd:YAG laser | Er:YAG laser | Nd:YAG laser |
| Intended use | See Chapter
5.5 b) | See Chapter
5.5 b) | To provide topical
heating for the
purpose of elevating
tissue temperature for
temporary relief of
muscle & joint pain
& stiffness, arthritis
pain or muscle
spasm; the temporary
increase in local
blood circulation
and/or promoting
relaxation of muscle. | See Chapter
5.5 b) | 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. |
| Laser mode | Pulsed | Pulsed | Pulsed | Pulsed | Pulsed |
| Wavelength | 2940 nm | 1064 nm | 1064 nm | 2940 nm | 1064 nm |
| Operating
voltage | 100-240 VAC | | 230 VAC | 100-240 VAC | |
| Current
frequency | 50/60 Hz | | 50/60 Hz | 50/60 Hz | |
| Power range | Up to 20 W | Up to 15 W | Up to 10 W | Up to 20 W | Up to 15 W |
| Fluence | Up to 48
J/cm² | Up to 300
J/cm² | 0.15-1.2 J/cm² | Up to 48
J/cm² | Up to 300
J/cm² |
| Pulse width | 50-1000 μs | 0.1-25 ms | 100-150 μs | 50-1000 μs | 0.1-25 ms |
| Repetition
rate | Up to 50 Hz | Up to 100
Hz | 10-30 Hz | Up to 50 Hz | Up to 100
Hz |
| Delivery
system | Contact and
non-contact
handpieces
connected to
the system
via an
articulated
arm | Contact and
non-contact
handpieces
connected to
the system
via a fiber
optic cable | Contact handpieces
connected to the
system via a fiber
optic cable | Contact and
non-contact
handpieces
connected to
the system via
an articulated
arm | Contact and non-contact
handpieces connected to the
system via a fiber optic
cable |
| Aiming beam | Laser diode 635 nm/650 nm
(red) or 520-532 nm
(green);