Leukoplakia
Pulpotomy as adjunct to root canal retreatment
Pulp extirpation
Removal of fibromae
Removal of granulated tissue
Caries removal, cavity preparation, enamel roughening -Sulcular debridement
Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement
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, 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;
Ophthalmology 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

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.).

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.

AI/ML Overview

This submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a performance study against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a performance study is not available in this document.

The document states: "The Fotona LightWalker 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."

This means the "study" demonstrating the device meets "acceptance criteria" (in the context of a 510(k)) is the comparison of technical specifications and intended uses to already cleared predicate devices. The "acceptance criteria" are effectively the specifications and intended uses of those predicate devices.

Here's the information that can be extracted, with explanations for what is not applicable or not provided:

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are the technical specifications and intended uses of the predicate devices. The "reported device performance" is the new device's technical specifications.

Table of Comparison for Nd:YAG Laser Wavelength

Characteristic	Acceptance Criteria (e.g., Predicate Devices)	Reported Device Performance (Fotona LightWalker Family - new submission)
Wavelength	1064 nm (across all predicates)	1064 nm
Laser media	Flashlamp pumped solid state rod (across all predicates)	Flashlamp pumped solid state rod
Aiming beam	650 nm (across most predicates)	650 nm or optionally 635 nm
Output mode	Pulsed (across all predicates)	Pulsed
Pulse energy	up to 10 J (K093162, K101817), up to 50 J (K101306), up to 20 J (K090126, K113702)	up to 10 J
Pulsewidth	0.1-25 ms (K093162, K101817), 0.1-50 msec (K101306, K090126, K113702)	0.1-25 ms
Repetition rate	up to 100Hz (K093162, K101817, K090126, K113702), up to 50 Hz (K101306)	up to 100Hz
Power	up to 15 W (K093162, K101817), up to 80 W (K101306), up to 30 W (K090126, K113702)	up to 15 W
Beam delivery	Fiber (across all predicates)	Fiber
User interface	Push button control (K093162, K101306, K090126, K113702), Touch screen control (K101817)	Touch screen control

Table of Comparison for Er:YAG Laser Wavelength

Characteristic	Acceptance Criteria (e.g., Predicate Devices)	Reported Device Performance (Fotona LightWalker Family - new submission)
Wavelength	2940 nm (across all predicates)	2940 nm
Laser media	Flashlamp pumped solid state rod (across all predicates)	Flashlamp pumped solid state rod
Aiming beam	650 nm (across all predicates)	650 nm or optionally 635 nm
Output mode	Pulsed (across all predicates)	Pulsed
Pulse energy	25-1500 mJ (K093162), 20-1500 mJ (K101817), 30-1500 mJ (K101306)	5-1500 mJ
Pulsewidth	50-1000 µs (K093162, K101817), 100-1500 µs (K101306)	50-1000 µs
Repetition rate	up to 50 Hz (across all predicates)	up to 50 Hz
Power	up to 20 W (across all predicates)	up to 20 W
Beam Delivery	Articulated arm (across all predicates)	Articulated arm
User interface	Push button control (K093162, K101306), Touch screen control (K101817)	Touch screen control

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" in the traditional sense for evaluating diagnostic performance or clinical outcomes. The "test" is the comparison of technical specifications and intended uses.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided. No "ground truth" for a performance study was established as part of this submission. The "ground truth" for substantial equivalence is the FDA's prior clearance of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided. There was no "test set" requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable / Not Provided. This device is a surgical laser, not an AI-based diagnostic tool. No MRMC studies were conducted or are relevant to this type of device and submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Provided. This is not an algorithm-only device. It is a physical laser system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is the FDA's prior clearance of the predicate devices, meaning their safety and effectiveness for their stated indications have already been accepted by the regulatory body.

8. The sample size for the training set

Not Applicable / Not Provided. There is no "training set" as this is not an AI/machine learning device. The "training" in a broad sense involved the design and testing of the laser system to ensure it met its own engineering specifications, but this is not reported in terms of a "training set."

9. How the ground truth for the training set was established

Not Applicable / Not Provided. As there is no training set mentioned, no ground truth for it was established.

Summary

{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

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 -

{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.

	FotonaFidelis III(K093162)	FotonaLight WalkerLaserSystem Family(K101817)	Fotona DynamisLaser SystemFamily(K101306)	Fotona XPNd:YAG LaserSystem Family(K090126)(K113702)	FotonaLightWalkerLaserSystemFamily(newsubmission)
Wavelength	1064 nm	1064 nm	1064 nm	1064 nm	1064 nm
Lasermedia	Flashlamppumpedsolid staterod	Flashlamp pumpedsolid state rod	Flash lamppumped solid staterod	Flashlamp pumpedsolid state rod	Flashlamppumpedsolid staterod
Aimingbeam	650 nm	650 nm	650 nm	650 nm	650 nm oroptionally635 nm
Outputmode	Pulsed	Pulsed	Pulsed	Pulsed	Pulsed
Pulseenergy	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
Repetitionrate	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
Beamdelivery	Fiber	Fiber	Fiber	Fiber	Fiber
Userinterface	Push buttoncontrol	Touch screencontrol	Push buttoncontrol	Push button control	Touch screencontrol

Table 3: Comparison table for Nd:YAG laser wavelength

Table 4: Comparison table for the Er: YAG wavelength

Er:YAG2940 nm	Fotona Fidelis III(K093162)	FotonaLight Walker LaserSystem Family(K101817)	Fotona Dynamis LaserSystem Family(K101306)	FotonaLightWalkerLaser SystemFamily(new submission)
Wavelength	2940 nm	2940 nm	2940 nm	2940 nm
Lasermedia	Flashlamppumped solid staterod	Flashlamp pumpedsolid state rod	Flashlamp pumped solidstate rod	Flashlamp pumpedsolid state rod
Aimingbeam	650 nm	650 nm	650 nm	650 nm oroptionally 635 nm

【4

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

Er:YAG2940 nm	Fotona Fidelis III(K093162)	FotonaLight Walker LaserSystem Family(K101817)	Fotona Dynamis LaserSystem Family(K101306	FotonaLightWalkerLaser SystemFamily(new submission)
Outputmode	Pulsed	Pulsed	Pulsed	Pulsed
Pulseenergy	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
Repetitionrate	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
BeamDelivery	Articulated arm	Articulated arm	Articulated arm	Articulated arm
Userinterface	Push buttoncontrol	Touch screen control	Push button control	Touch screencontrol

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

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.