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510(k) Data Aggregation
K Number
K143723Device Name
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
Manufacturer
FOTONA D.D.
Date Cleared
2015-04-09
(101 days)
Product Code
GEX, ONG
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOTONA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fotona Dynamis Er: YAG laser is intended for surgical incision/excision, cutting ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
· Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing;
· ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
· Oral/Maxillofacial Indications: Oral and glossal lesions;
· Ophtalmology Indications: Soft tissue surrounding the eye ;
· Intra-oral soft tissue incision, excision, ablation, coagulation;
· 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 is necessary;
· 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;
· Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;
· The Fotona F-22 Handpiece is intended for:
- In fractionated mode:
Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;
- In non-fractionated mode:
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 is necessary;
· The Fotona FS-01 Handpiece is intended for:
- Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;
**Dynamis Nd:YAG laser (1064 nm wavelength):**
The Fotona Dynamis Nd: YAG laser is intended for incision, ablation, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.
· Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy;
· Treatment of Aphthous Ulcers; · Excision and Vaporization of Herpex Simplex I and II; · Laser assisted uvulopaletoplasty (LAUP); · Laser assisted lipolysis; · 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 if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regime: · Treatment of wrinkles; · Treatment of mild to moderate inflammatory acne vulgaris; · Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins; · Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: o Matrixectomy o Radical nail excision o Periungual and subungual warts o Plantar warts o Neuromas o Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) · Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.
Device Description
The Fotona Dynamis Pro 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 handpiece (in the case of the Nd: Y AG 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 energy and the laser pulse duration. The user activates laser emission by means of a footswitch.
The Fotona Dynamis Pro Family is designed to operate in single wavelength (Nd:Y AG or Er: Y AG) configurations (models) and dual wavelength (Nd: Y AG and Er: Y AG) configurations (models).
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K Number
K132806Device Name
FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
Manufacturer
FOTONA D.D.
Date Cleared
2014-07-11
(308 days)
Product Code
GEX, ONG
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOTONA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fotona F-22 Handpiece is intended for:
. In fractionated mode:
Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;
: ` In non-fractionated mode:
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 is necessary;
The Fotona FS-01 Handpiece is intended for:
Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece.
Device Description
The F-22 Handpiece and FS-01 Handpiece each attach to the Dynamis Er: Y AG/Nd: YAG Laser Systems. The Fotona Dynamis Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The F-22 handpiece and FS-01 handpiece are designed to be used with the Er:YAG (2940 nm) laser wavelength only. The laser system console consists of a flashlamp pumped Er: YAG laser source, power supply, water colling unit, electronics, and a footswitch. Electrical power is supplied to the console by the facility's power source. A red diode aiming beam (650 nm) is combined with the therapeutic Er:YAG laser beam. 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). Fotona's power supply and electronics, integrated into the laser system, allows control of the laser energy and the laser pulse duration. The user activates laser emission by means of a footswitch.
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K Number
K121508Device Name
LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
Manufacturer
FOTONA D.D.
Date Cleared
2012-12-12
(205 days)
Product Code
PDZ, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOTONA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Er:YAG laser (2940 nm wavelength) in dentistry:
Intra-oral soft tissue surgery (incision, excision, ablation coagulation)
- Leukoplakia
- Pulpotomy as adjunct to root canal retreatment
- Pulp extirpation
- Removal of fibromae
- Removal of granulated tissue
- Caries removal, cavity preparation, enamel roughening -Sulcular debridement
- Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement
- 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.
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K Number
K113702Device Name
FOTONA XP ND: YAG LASER SYSTEM
Manufacturer
FOTONA D.D.
Date Cleared
2012-03-28
(103 days)
Product Code
PDZ, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOTONA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fotona XP Nd:YAG Laser System Family and its accessories are intended for use in the following procedures:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy ー
- Radical nail excision -
- Periungual and subungual warts ー
- Plantar warts l
- Neuromas -
- Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes ー Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
Device Description
The Fotona XP Nd:YAG Laser System Family is based on thè Nd:YAG (1064 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The Nd: YAG laser is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial bcam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by an optical fiber delivery system to an optical handpiece. Optionally, the laser beams can be guided through fiber having SMA905 connector on the proximal end and bare fiber on distal end. The user activates laser emission by means of a footswitch.
The Nd: YAG (1064 nm) laser can be operated with variable pulse durations in the range of 0.1-50 msec, with repetition rates up to 100 Hz and laser pulse energies up to 20 J. Depending on the type of treatment, the user can choose between a PULSE mode user interface, and a QCW (Quasi-Continuous Wave) mode user interface. The laser operation is the same for both modes, the difference is only in the laser parameters that can be directly selected from the keyboard.
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K Number
K101306Device Name
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
Manufacturer
FOTONA D.D.
Date Cleared
2011-07-01
(417 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOTONA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fotona Dynamis Laser System Family, and its accessories, are intended for use in the following procedures:
Dynamis Er: YAG laser (2940 nm wavelength)
- 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;
- Ophtalmology Indications: Soft tissue surrounding the eye;
- Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;
- 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 is necessary;
- Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;
Dynamis Nd: YAG laser (1064 nm wavelength):
- Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy;
- Laser assisted lipolysis;
- 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;
- Treatment of wrinkles;
- Treatment of mild to moderate inflammatory acne vulgaris;
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins:
- Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.
Device Description
The Fotona Dynamis 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 beans 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 energy and the laser pulse duration. The user activates laser emission by means of a footswitch.
The Fotona Dynamis Laser System Family is designed to operate in five configurations (models):
- XS Dynamis: Single Er:YAG laser system
- XP Dynamis: Single Nd:YAG laser system
- SP Dynamis: Combined Er: YAG/Nd: YAG laser system
- XP Spectro: Single Nd:YAG laser system, with lower average output power of Nd:YAG laser and smaller housing
- SP Spectro: Combined Er:YAG/Nd:YAG laser system, with lower average output power of -Nd:YAG laser and unchanged specifications of Er:YAG laser, and smaller housing.
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K Number
K101817Device Name
LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N
Manufacturer
FOTONA D.D.
Date Cleared
2010-11-22
(145 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOTONA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LightWalker Er:YAG laser, and its accessories, are intended for use 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/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 mosiac verrucae, matrixectomy
The LightWalker Nd:YAG laser, and its accessories, are intended for use 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 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
- Photocoagulation and hemostasis of pigmented and vascular lessons, such as, but not limited to, port wine stains, hemaongiomae, warts, telengiectasiae, venus lake, leg veins and spider veins
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
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 red diode aiming beam (650 mm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical hand piece (in the case of the Nd: YAG laser).
The Er:YAG laser is capable of delivering up to 1.5 J of laser energy in pulses with durations of up to 1000 us and frequencies (repetition rates) of up to 50 Hz. The maximum average output power is 20 W.
For aesthetic indications, the Nd:YAG laser is capable of delivering laser fluences up to 300 J/cm² in pulses with durations of up to 25 ms. For dental indications, it is capable of delivering laser pulses with durations of up to 320 us, frequencies (repetition rates) up to 100 Hz and a maximum output power of 15 W.
Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows ultimate control of the laser energy and the laser pulse duration. This ensures treatment precision, patient comfort, safety and ease-of-use in all treatments.
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K Number
K093162Device Name
FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID
Manufacturer
FOTONA D.D.
Date Cleared
2010-01-22
(108 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOTONA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 ー
- 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 = curretage
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, tissue ablation and vessel coagulation is necessary;
- Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;
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
- w Gingival incision and excision
- Gingivectomy -
- Gingivoplasty -
- Hemostasis -
- Implant recovery -
- Incision and drainage of abscess -
- Laser assisted uvulopaletoplasty (LAUP) -
- -Operculectomy
- Oral papillectomies l
- Pulpotomy and pulpotomy as an adjunct to root canal therapy ー
- 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 ー
- 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 ー
- Treatment of aphtous ulcers ー
- -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
- । Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
- Treatment of wrinkles -.
- Treatment of mild to moderate inflammatory acne vulgaris
Device Description
The Fotona Fidelis III laser system family is based on Er: Y AG (2940 nm) and Nd: Y AG (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 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 hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical hand piece (in the case of the Nd. YAG laser).
The Er:Y AG laser is capable of delivering up to 1.5 J of laser energy in pulses with durations of up to 1000 us and frequencies (repetition rates) of up to 50 Hz. The maximum average output power is 20 W.
The Nd: YAG laser is capable of delivering laser fluences up to 300 J/cm² in pulses with durations of up to 25 ms. and laser pulses with durations of up to 320 us. frequencies (repetition rates) up to 100 Hz and a maximum output power of 15 W.
Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows ultimate control of the laser energy and the laser pulse duration. This ensures treatment precision, patient comfort, safety and case-of-use in all treatments.
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K Number
K090126Device Name
FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2,
Manufacturer
FOTONA D.D.
Date Cleared
2009-06-29
(159 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOTONA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nd: YAG laser (1064 nm wavelength) in dermatology and other surgical areas:
- Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis
- 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
- Treatment of wrinkles -
- Treatment of mild to moderate inflammatory acne vulgaris -
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
- Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities
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 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
Device Description
The Fotona XP Laser System Family is based on the Nd: YAG (1064 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The Nd: YAG laser is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path, using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by an optical fiber delivery system to an optical handpiece. Optionally, the laser beams can be guided through fiber having SMA905 connector on the proximal end bare fiber on distal end. The user activates laser emission by means of a footswitch.
The Nd:YAG (1064 nm) laser can be operated with variable pulse durations in the range of 0.1-50 msec, with repetition rates up to 100 Hz and laser pulse energies up to 10 J. Depending on the type of treatment, the user can choose between a PULSE mode user interface, and a OCW (Ouasi-Continuous Wave) mode user interface. The laser operation is the same for both modes, the difference is only in the laser parameters that can be directly selected from the keyboard.
In the PULSE user interface mode the user can directly select the handpiece treatment spot size, laser fluence, pulse duration and pulse repetition rate. This mode is intended primarily for treatments at relatively small repetition rates, or in individual pulses, and at relatively high pulse energies. In this mode, a major expected treatment effect is the selective photothermolysis of target chromophores in soft tissue. For this reason it is more effective and safer that the energy is delivered to target chromophores in a relatively short time, in order not to cause damage to the surrounding tissue. Typically, the illuminated areas, or spotsizes are larger than 1 mm. A spotsize is determined by choosing and adjusting the handpiece. In this mode, the relevant and sufficient treatment parameters that have been accepted by the medical community are laser pulse energy, laser pulse fluence (energy over the spot-size area), pulse duration and pulse repetition rate.
In the QCW user interface mode the user can directly select the laser pulse repetition rate, pulse width and the average laser power. This mode is intended primarily for treatments at relatively high repetition rates and small pulse energies. In this mode, a major expected treatment effect is incision, excision and coagulation of tissue via heating of the tissue in close contact with the fiber delivery of a known diameter (typically smaller than 1.0 mm), and over a time typically longer than 0.5 sec. For this reason, in this mode, average power, repetition rate (frequency) and pulse-width are the relevant and sufficient treatment parameters, accepted by the medical community, for performing various dental or surgical procedures.
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K Number
K083889Device Name
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
Manufacturer
FOTONA D.D.
Date Cleared
2009-04-23
(115 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOTONA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fotona OX Nd: YAG/KTP Laser System Family is indicated for incision, excision, ablation and vaporization of soft tissue for general dermatology.
Specific Indications:
1064 nm wavelength in Q-switched mode:
- Removal of dark ink (black, blue and brown) tattoos
- Treatment of nevus of Ota
- Treatment of common nevi
- Removal or lightening of unwanted hair
- Skin resurfacing procedures for the treatement of acne scars and wrinkles
1064 nm wavelength in non- Q-switched mode:
- 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
- Photocoagilation and hemostasis of pigmented and vascular lesions, such as, but not limited to. port wine stains, hemaongiomae, warts, telangiectasiae, venus lake, leg veins and spider veins
- Coagulation and hemostasis of soft tissue
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 mm dye converter handpieces):
- Removal of light ink (red, sky blue, green, tan, purple, and orange) tatoos
- Treatment of vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angioma
- cherry angioma
- spider nevi
- Treatment of pigmented lesions including, but not limited to:
- cafe-au-lait birthmarks
- solar lentigines
- senile lentigines
- -Becker's nevi
- freckles
- common nevi
- nevus spilus
- Treatment of seborrheic keratosis
- Treatment of post inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.
Device Description
The Fotona QX laser system family is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd: YAG (532 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The frequency doubled KTP Nd: YAG wavelength is achieved by directing the Nd: YAG laser beam through a frequency doubling non-linear crystal. The Nd: YAG laser is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing variable spot handpiece. Optionally, the KTP Nd: YAG beam can be guided to a 585nm dye converter handpiece, or to a 650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 mm or a 650 nm wavelength, correspondingly. Both lasers are used in non-contact mode. The user activates laser emission by means of a footswitch.
The Nd:YAG (1064 nm) laser can be operated in a Q-switched (nominal pulse duration 5-20 nsec) and in a non-Qswitched mode (nominal pulse duration 0.25 msec) of operation. The KTP: YAG (532 nm) laser with optional 585 nm and 650 nm wavelengths can be operated only in a Q-switched mode (nominal pulse duration 5-20 nsec).
In the O-switched mode, the Nd: Y AG (1064 nm) laser is capable of delivering up to 1.6 J of laser energy. Spot sizes available range from 2 to 8 mm.
In the non-Q-switched mode, the Nd: YAG (1064 nm) laser is capable of delivering up to 5 J of laser energy. Spot sizes range from 2 to 8 mm.
The frequency doubled Nd:YAG (532 nm) KTP laser delivers up to 0.6 J of laser energy in 5-20 nanosecond pulses. Spot sizes available range from 2 to 8 mm.
All three modes of operation are intended to be used for incision/excision, ablation, vaporization of soft tissue in general dermatology and for the indications for use as stated below.
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K Number
K083034Device Name
FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F
Manufacturer
FOTONA D.D.
Date Cleared
2009-02-04
(117 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOTONA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fotona XD Diode Laser System, and its accessories, are intended for use in
- Periodontology for
- Laser soft tissue curettage r
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Oral Soft Tissue surgery for
- Gingivectomy
- Gingivoplasty
- Fibroma removal
- Treatment of Aphthous Ulcers
- Crown Lenghtening
- Frenectomy
- Papillectomy
- Photocoagulation
- Cosmetic Dentistry for
- Light activation for bleaching materials for teeth whitening -
- Lasers-assisted bleaching/whitening of the teeth -
Device Description
The Fotona XD Diode Laser System is based on a semiconductor laser that operates in the nearinfrared range of the electromagnetic spectrum. The laser source consists of a compact semiconductor laser diode module that emits laser light at a wavelength of 810 nm in continuous wave mode or pulse operation mode from 20 Hz to 10 kHz. The output power can be set from 250 m W to 7.0W. A red diode aiming beam (650 nm) is combined with the therapeutic laser beam and , both beams are guided through an optical fiber delivery unit and an optical handpiece to the treatment site.
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