(108 days)
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
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.
The provided text is a 510(k) summary for the Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family. It describes the device, its intended use, and a statement of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
The core of the document is a regulatory submission demonstrating that the new device is "substantially equivalent" to previously cleared devices. This type of submission relies on showing that the new device has "the same intended use and the same technological characteristics as the predicate device" or "has the same intended use as the predicate device and has different technological characteristics than the predicate device, but the different technological characteristics do not raise different questions of safety and effectiveness."
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text, as this information is not present. The document focuses on demonstrating substantial equivalence to existing devices rather than a de novo clinical study with specific performance metrics and acceptance criteria.
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09 3162
Page 1 of (3)
5. 510(k) Summary
ﺎ ﻓﻲ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
Submitter's Name: Fotona d.d. Stegne 7 SI-1210 Ljubljana, Slovenia Phone: +386 15009100 + 386 5009 200 Fax: Contact Person: Stojan Trošt, QA&RA Manager Phone: + 386 1 5009 299 E-mail: stojan.trost@fotona.com
Date: September 29, 2009
| Device Name: | |
|---|---|
| Trade name: | Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family |
| Common name: | Er:YAG/Nd:YAG Surgical Laser |
| Classification name: | Instruments, Surgical, Powered, Laser |
| 79-GEX |
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.
INTENDED USE
The Fidelis III 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
::
JAN 22 2010 .
510(k) Submission: Fotona Fidelis III Laser System v2
{1}------------------------------------------------
- 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 osscous tissue (bone) ।
- Osteotomy,osseous crown lengthening, osteoplasty -
- -Apicectomy surgery
- Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open ー curretage
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 1
The Fidelis III 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 l
- Fibroma removal -
- Frenectomy and frenotomy -
- Gingival troughing for crown impressions -
- Gingivectomy ー
- Gingivoplasty =
- Gingival incision and excision ー
- 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 ー
- Reduction of gingival hypertrophy
{2}------------------------------------------------
- .............................................................................................................................................................................. Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
- Removal of post-surgical granulations l
- Soft tissue crown lengthening -
- Sulcular debridement or soft tissue curettage (removal of discased 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 l
- Vestibuloplasty -
In dermatology and other surgical areas, for:
- Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of l 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, telengiectasiae, rosacea, venus lake, leg veins and spider veins
- Treatment of wrinkles ।
- Treatment of mild to moderate inflammatory acne vulgaris -
STATEMENT OF SUBSTANTIAL EQUIVALENCE
The Fidelis III laser system family shares the same indication for use, similar design and functional features with, and therefore Fotona d.d. believes that its Fidelis III laser system family is substantially equivalent to
- a) Fotona Fidelis Er: YAG Laser System (K001527) previously cleared for incision, excision, vaporization, ablation and coagulation of soft and hard tissue in the mouth;
- b) Fotona Fidelis Plus Nd:YAG Laser System (K024204) previously cleared as an accessory for Fotona Fidelis Er:YAG Laser System (K001527) for incision, excision and coagulation of intra oral soft tissue, including the marginal and inter dental gingiva;
- c) Fotona XP Plus Nd:YAG Family (K050293) previously cleared for surgical and aesthetic applications in soft tissue in the medical specialities of general and plastic surgery and dermatology:
- d) Fotona Dualis Nd: YAG/Er: YAG Laser System (K021548) previously cleared for surgical incision/excision, vaporization and coagulation of soft and hard tissue;
- e) Hoya ConBio VersaWave Dental Er:Y AG Laser System (K041710) previously cleared for various hard tissue and soft tissue dental indications;
- Cooltouch Nd: YAG Laser System previously cleared for the treatment of mild to moderate ಗಿ inflammatory acne vulgaris (K040131).
- g) Laserscope Gemini Laser System previously cleared for the treatment of mild to moderate inflammatory acne vulgaris (K034011)
- h) KaVo KEY Laser 1243+ (K030146) previously cleared for removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curretage.
Details are provided in the Substantial Equivalence Discussion Section of this submission.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with flowing lines, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S." is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 2 2 2010
Fotona d.d. % Mr. Stojan Trost Quality Assurance and Regulations Affairs Manager Stegne 7, 1210 Ljubljana, Slovenia.
Re: K093162
Trade/Device Name: Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX
Dated: January 13, 2010 Received: January 15, 2010
Dear Mr. Trost:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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.
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
{4}------------------------------------------------
Page 2 - Mr. Stojan Trost
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Mishranding 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
g 3/62
Page 1 of 2
4. Indications for Use Statement
510(k) Number (if known):
Device Name: Fotona Fidelis III Er: YAG/ Nd: YAG Laser System Family
Indication 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 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 -
x I and II
Mark H. Millkum
Sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093162
510(k) Submission: Fotona Fidelis III Laser System v2
{6}------------------------------------------------
093162
Page 2 of 2
- 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
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 Surgical, Orthopedia,
. ! Restorative Devices
ber K093162
13/31
510(k) Submission: Fotona Fidelis III Laser System v2
§ 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.