K Number
K093162
Device 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
Date Cleared
2010-01-22

(108 days)

Product Code
Regulation Number
878.4810
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.
More Information

Not Found

No
The document describes a laser system with different wavelengths and pulse control technology, but there is no mention of AI or ML in the intended use, device description, or any other section.

Yes.
The device is used to perform various medical and surgical procedures across multiple specialties, including dentistry, dermatology, ENT, general surgery, and podiatry, aimed at treating diseases, injuries, and other conditions.

No

The device description and intended use/indications for use only describe surgical and therapeutic applications of the laser system (e.g., incision, excision, ablation, coagulation, removal of tissue, treatment of lesions, reduction of hyperplasia, hair removal, photocoagulation). There is no mention of any diagnostic function.

No

The device description clearly details hardware components including laser sources, optical cavities, an articulated arm, optical handpieces, and an optical fiber delivery system. It is a physical laser system, not software only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Function: The description clearly states that this device is a laser system (Er:YAG and Nd:YAG) used for surgical procedures on various anatomical sites (intra-oral, skin, bone, etc.). It directly interacts with and modifies tissue.
  • Intended Use: The intended uses listed are all surgical procedures (incision, excision, ablation, coagulation, cutting, removal, treatment of lesions, hair removal, etc.). These are not diagnostic tests performed on specimens outside the body.

The device is a therapeutic and surgical laser system, not a diagnostic device that analyzes samples.

N/A

Intended Use / 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 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

Product codes (comma separated list FDA assigned to the subject device)

79-GEX
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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intra-oral, skin, ENT (ear, nose, throat), oral/maxillofacial, general surgical areas, podiatry.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K001527, K024204, K050293, K021548, K041710, K040131, K034011, K030146

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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

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

0

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