LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N

K121508 · Fotona D.D. · PDZ · Dec 12, 2012 · General, Plastic Surgery

Device Facts

Record IDK121508
Device NameLIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
ApplicantFotona D.D.
Product CodePDZ · General, Plastic Surgery
Decision DateDec 12, 2012
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4810
Device ClassClass 2
AttributesTherapeutic

Intended Use

The LightWalker Er: YAG laser, and its accessories, are in dentistry, dermatology and other surgical areas in the following procedures: In dentistry, for: Intra-oral soft tissue surgery (incision, excision, ablation, coagulation) Leukoplakia Pulpotomy as adjunct to root canal retreatment Pulp extirpation Removal of fibromae Removal 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 In dermatology and other surgical areas, for: Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, skin tags, keratoses, verrucae, 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 mosiac verrucae, matrixectomy Ophtalmology Indications: Soft tissue surrounding the eye Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma; The LightWalker Nd: YAG laser, and its accessories, are in dentistry, dermatology and other surgical areas in the following procedures: In dentistry, for: 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 imflamed 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 In dermatology and other surgical areas, for: 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. 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. Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telengiectasiae, 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 The Fotona LightWalker Laser System Family is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

Device Story

LightWalker Laser System is a dual-wavelength (Er:YAG 2940 nm and Nd:YAG 1064 nm) surgical laser console. System utilizes flashlamp-pumped solid-state rods; incorporates Variable Square Pulse (VSP) technology for pulse duration control. Aiming beam (650 nm diode) assists targeting. Energy delivered via articulated arm (Er:YAG) or optical fiber (Nd:YAG) to manual/scanner handpieces. Operated by clinicians via footswitch. Microprocessor controls parameters, safety, and thermal management via internal closed-loop water-air heat exchanger. Used in clinical settings for tissue ablation, incision, coagulation, and vaporization across multiple specialties. Output allows precise tissue interaction, facilitating surgical procedures and therapeutic outcomes like hair reduction or onychomycosis treatment.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Dual-wavelength (2940 nm Er:YAG, 1064 nm Nd:YAG) flashlamp-pumped solid-state laser. VSP (Variable Square Pulse) technology. Microprocessor-controlled. Internal closed-loop water-air heat exchanger. 650 nm diode aiming beam. Fiber or articulated arm delivery. Touch screen interface.

Indications for Use

Indicated for patients requiring dental, dermatological, ENT, oral/maxillofacial, general surgical, podiatric, ophthalmological, or gynecological procedures involving soft tissue or bone. Includes hair reduction (all skin types I-VI), treatment of vascular/pigmented lesions, acne, wrinkles, and temporary increase of clear nail in onychomycosis patients.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ # 5. 510(k) Summary Submitter's Name: Contact Person: <121508 DEC 1 2 2012 1 Date: January 11, 2012 Device Name: LightWalker Family Trade name: Common name: Er:YAG/Nd:YAG Surgical Laser Classification name: Instruments, Surgical, Powered, Laser 79-GEX Fotona d.d. 1210 Ljubljana, Slovenia Phone: +386 15009100 Phone: + 386 1 5009 299 + 386 5009 200 Stojan Trošt, QA&RA Manager E-mail: stojan.trost@fotona.com Stegne 7 Fax: ### DEVICE DESCRIPTION The Fotona Light Walker Laser System Family is based on Er: YAG (2940 nm) and Nd: YAG (1064 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er: YAG and Nd: YAG crystals. A red diode aiming beam (650 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical manual or scanner hand piece (in the case of the Nd: YAG laser). Optionally, the Nd: YAG therapeutic and aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end. Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows control of the laser pulse duration. The user activates laser emission by means of a footswitch. ### INTENDED USE The LightWalker Er: YAG laser, and its accessories, are in dentistry, dermatology and other surgical areas in the following procedures: In dentistry, for: - Intra-oral soft tissue surgery (incision, excision, ablation, coagulation) l - Leukoplakia 1 - Pulpotomy as adjunct to root canal retreatment - - Pulp extirpation - - Removal of fibromae . - Removal granulated tissue - - Caries removal, cavity preparation, enamel roughening ー - 'Sulcular debridement - 11 {1}------------------------------------------------ - 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) l - Osteotomy,osseous crown lengthening, osteoplasty - - Apicectomy surgery - - Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curetage - In dermatology and other surgical areas, for: - Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, skin tags, keratoses, verrucae, and skin resurfacing - ENT Surgery Indications:ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia l - Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy l - 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 mosiac verrucae, matrixectomy - - Ophtalmology Indications: Soft tissue surrounding the eye ; l - Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma; The LightWalker Nd: YAG laser, and its accessories, are in dentistry, dermatology and other surgical areas in the following procedures: In dentistry, for: - Excisional and incisional biopsies ー - Excision and vaporization of herpes simplex I and II l - Exposure of unerupted teeth - - Fibroma removal l - Frenectomy and frenotomy - - Gingival troughing for crown impressions - - Gingivectomy - - Gingivoplasty - - Gingival incision and excision 1 - Hemostasis - - Implant recovery - - Incision and drainage of abscess ー - Laser assisted uvulopaletoplasty (LAUP) - - Operculectomy - - -Oral papillectomies - Pulpotomy and pulpotomy as an adjunct to root canal therapy l - Reduction of denture hyperplasia 1 - -Reduction of gingival hypertrophy - Removal of filling material such as gutta percha or resin as adjunct treatment during root canal = therapy {2}------------------------------------------------ - -Removal of post-surgical granulations - Soft tissue crown lengthening - - Sulcular debridement or soft tissue curettage (removal of diseased or imflamed soft tissue in the l periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility) - Tissue retraction for impression ー - Treatment of aphtous ulcers ﺖ - Vestibuloplasty l In dermatology and other surgical areas, for: - 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. 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. - Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, । port wine stains, hemaongiomae, warts, telengiectasiae, 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: ー - Matrixectomy - - Periungual and subungual warts - - Plantar warts ー - Radical nail excision ー - Neuromas - The Fotona LightWalker Laser System Family is indicated for use for the temporary increase of clear nail in patients with onvchomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.). #### 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 devices. The output characteristics are for the intended use the same as those of the predicate devices. All systems are based on VSP (Variable Square Pulse) power supply technology. All lasers utilize class I aiming beams which pose no hazard to the user. All systems are microprocessor controlled devices. The microprocessor control regulates normal operation, permits parameter selection and avoids hazard incidence. All systems utilize an internal closed loop water-air heat exchanger circuit for optimal thermal control of the laser cavity. The risk and benefits for the Fotona LightWalker Laser System family are identical to the predicate devices when used for similar clinical applications. A comparison of the technical specifications for the intended use of the LightWalker Laser system {3}------------------------------------------------ family with the previously cleared devices is provided in Table 3 (for the Nd: YAG wavelength) and Table 4 (for the Er:YAG wavelength) below. | | Fotona<br>Fidelis III<br>(K093162) | Fotona<br>Light WalkerLaser<br>System Family<br>(K101817) | Fotona Dynamis<br>Laser System<br>Family<br>(K101306) | Fotona XP<br>Nd:YAG Laser<br>System Family<br>(K090126)<br>(K113702) | Fotona<br>LightWalker<br>Laser<br>System<br>Family<br>(new<br>submission) | |--------------------|-------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------| | Wavelength | 1064 nm | 1064 nm | 1064 nm | 1064 nm | 1064 nm | | Laser<br>media | Flashlamp<br>pumped<br>solid state<br>rod | Flashlamp pumped<br>solid state rod | Flash lamp<br>pumped solid state<br>rod | Flashlamp pumped<br>solid state rod | Flashlamp<br>pumped<br>solid state<br>rod | | Aiming<br>beam | 650 nm | 650 nm | 650 nm | 650 nm | 650 nm or<br>optionally<br>635 nm | | Output<br>mode | Pulsed | Pulsed | Pulsed | Pulsed | Pulsed | | Pulse<br>energy | up to 10 J | up to 10 J | up to 50 J | up to 20 J | up to 10 J | | Pulsewidth | 0.1-25 ms | 0.1-25 ms | 0.1 - 50 msec | 0.1 - 50 msec | 0.1-25 ms | | Repetition<br>rate | up to 100Hz | up to 100Hz | up to 50 Hz | up to 100Hz | up to 100Hz | | Power | up to 15 W | up to 15 W | up to 80 W | up to 30 W | up to 15 W | | Beam<br>delivery | Fiber | Fiber | Fiber | Fiber | Fiber | | User<br>interface | Push button<br>control | Touch screen<br>control | Push button<br>control | Push button control | Touch screen<br>control | Table 3: Comparison table for Nd:YAG laser wavelength Table 4: Comparison table for the Er: YAG wavelength | Er:YAG<br>2940 nm | Fotona Fidelis III<br>(K093162) | Fotona<br>Light Walker Laser<br>System Family<br>(K101817) | Fotona Dynamis Laser<br>System Family<br>(K101306) | Fotona<br>LightWalker<br>Laser System<br>Family<br>(new submission) | |-------------------|----------------------------------------|------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------| | Wavelength | 2940 nm | 2940 nm | 2940 nm | 2940 nm | | Laser<br>media | Flashlamp<br>pumped solid state<br>rod | Flashlamp pumped<br>solid state rod | Flashlamp pumped solid<br>state rod | Flashlamp pumped<br>solid state rod | | Aiming<br>beam | 650 nm | 650 nm | 650 nm | 650 nm or<br>optionally 635 nm | 【4 {4}------------------------------------------------ | Er:YAG<br>2940 nm | Fotona Fidelis III<br>(K093162) | Fotona<br>Light Walker Laser<br>System Family<br>(K101817) | Fotona Dynamis Laser<br>System Family<br>(K101306 | Fotona<br>LightWalker<br>Laser System<br>Family<br>(new submission) | |--------------------|---------------------------------|------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------| | Output<br>mode | Pulsed | Pulsed | Pulsed | Pulsed | | Pulse<br>energy | 25 - 1500 mJ | 20 - 1500 mJ | 30 - 1500 mJ | 5-1500 mJ | | Pulsewidth | 50 - 1000 $μ$ s | 50 - 1000 $μ$ s | 100 - 1500 $μ$ s | 50 - 1000 $μ$ s | | Repetition<br>rate | up to 50 Hz | up to 50 Hz | up to 50 Hz | up to 50 Hz | | Power | up to 20 W | up to 20 W | up to 20 W | up to 20 W | | Beam<br>Delivery | Articulated arm | Articulated arm | Articulated arm | Articulated arm | | User<br>interface | Push button<br>control | Touch screen control | Push button control | Touch screen<br>control | ### STATEMENT OF SUBSTANTIAL EQUIVALENCE The Fotona LightWalaker Er:YAG/Nd:YAG Laser System Family is substantially equivalent to Fotona LightWalker Laser System Family (K101817), Fotona Fidelis III Er:YAG/Nd: YAG Laser System Family (K093162), Fotona Dynamis Er:YAG/Nd:YAG Laser System Family (K101306), Fotona XP Nd:YAG Laser System Family (K090126) and (K113702), Cutera GenesisPlus Laser System (K103626) and PinPointe FootLaser (K093547). The Fotona LightWalker Er: YAG/Nd:YAG Laser System Family is substantially equivalent in terms of indications for use and technology based on technical characteristics. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and clean, and it is easily recognizable. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 13, 2013 Fotona D.D. % Mr. Stojan Trošt Quality Assurance and Regulatory Affairs Manager Stegne 7 Ljubljana, Slovenia 1210 Re: K121508 Trade/Device Name: LightWalker 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: PDZ, GEX Dated: December 07, 2012 Received: December 10, 2012 Dear Mr. Trošt: This letter corrects our substantially equivalent letter of December 12, 2012. 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. The general controls provisions of the Act include requirements for annual registration. Isting 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. {6}------------------------------------------------ Page 2 - Mr. Stojan Trošt 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetw/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. > Sincerely yours, FOR Peter D. Rumm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## 4. Indications for Use Statement 510(k) Number K121508 #### Device Name: LightWalker Family 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 l - Caries removal, cavity preparation, enamel roughening -Sulcular debridement - Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root । canal preparation including enlargement - Cutting, shaving, contouring and resection of oral osseous tissue (bone) ﺍ - Osteotomy, osseous crown lengthening, osteoplasty । - Apicectomy surgery l - 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 l tags, keratoses and skin resurfacing; - ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; - Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectorny; । - 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, matrixectorny; l - Ophthalmology Indications: Soft tissue surrounding the eye; ເ - Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma; ## Neil R Ogden 2012.12.12 08:47:12 -05'00' (Division Sign-Off) Division of Surgical Devices 510(k) Number {8}------------------------------------------------ Nd:YAG laser (1064 nm wavelength) in dentistry: - Excisional and incisional biopsies l 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 । - l. Reduction of denture hyperplasia - Reduction of gingival hypertrophy l Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy - Removal of post-surgical granulations i 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 ı Treatment of aphtous ulcers Vestibuloplasty - Neil R Ogden 2012.12.12 08:47:38 -05'00' (Division Sign-Off) Division of Surgical Devices K121508 510(k) Number {9}------------------------------------------------ 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. 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. Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasia, 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 The Fotona Light Walker Laser System Family is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.). Prescription Use: X (21 CFR 801 Subpart D) AND/OR Over-The-Counter Use: (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R Ogden 2012.12.12 08:48:11 -05'00' (Division Sign-Off) Division of Surgical Devices 510(k) Number K121508
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