The LiteDuo Dental Laser System is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. In addition, the system is intended for light activation of bleaching materials for teeth whitening.

This includes the following:

Er:YAG Laser:

Hard Tissue Indications of Erbium Laser Energy:

Caries removal, Cavity preparation, Enamel etching, Enameloplasty, excavation of pits and fissures for placement of sealant,

Bone Indications of Erbium Laser Energy:

Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue (bone), Apicoectomy - amputation of the root end, Cutting bone to prepare a window access to the apex (apices) of the root(s), Osseoplasty, Osteotomy, Osseous crown lengthening

Soft Tissue and Periodontal Indications of Erbium Laser Energy:

Excisional and incisional biopsies, Exposure of unerupted teeth, Incision drainage of abscesses, Gingival incision and excision, and a Gingivoplasties, Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias, Gingival troughing for crown impressions. Hemostasis. Implant recovery. Frenectomies and frenotomies, Fibromatosis (fibroma removal), Benign and malignant lesion removal, Operculectomy, Oral papillectomies, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Preprosthetic surgery: flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papillomas, fibromatoses benign growths, Vestibuloplasty, Sulcular debridement (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)

Endodontal Indications of Erbium Laser Energy:

Tooth preparation to obtain access to root canal, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Pulp extirpation, Root canal debridement and cleaning, Root canal preparation including enlargement.

Diode Laser:

Marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gigngivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision and draining of tissue retraction, for impressions, papillectomy, abscesses. vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers. leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Device Description

The LITEDUO Dental Laser is an advanced microprocessor-controlled laser system, composed of the following units:

. The control panel;
. The Er: Y AG and Diode laser applicators;
High-voltage power supply, capacitor bank and switching module;
. Diode driver and Diode laser array;
The cooling system;
An Er: YAG laser energy verification module.

AI/ML Overview

The provided text is a 510(k) summary for the LITEDUO Dental Laser System, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission generally relies on established safety and efficacy of the predicate devices and existing scientific literature, rather than new primary clinical studies with specific acceptance criteria and detailed performance metrics of the device itself.

Therefore, the document does not contain the acceptance criteria and study details as requested in the prompt. The summary explicitly states:

"Due to the comprehensive animal and clinical study performed in scientific research and published in literature, and since the power, wavelength, pulse duration and frequency of the LITEDUO Dental Laser System are well within the previous cleared values, Light Instruments believes that animal and clinical studies are not required to determine the safety and efficacy of the device."

This indicates that Light Instruments is asserting that the device's safety and efficacy are already established by existing scientific literature and the performance of previously cleared devices, and thus a new study against specific acceptance criteria for the LITEDUO device was not performed or submitted in this 510(k).

The document mentions compliance with general performance standards (21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products, and various EN and IEC standards), which are regulatory and safety standards, not performance metrics of the device in a clinical context against defined acceptance criteria.

In summary, the requested information cannot be extracted from the provided text because the 510(k) submission for the LITEDUO Dental Laser System did not involve a new clinical study to prove the device meets specific acceptance criteria.

Summary

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MAY 1 3 2008

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510(K) SUMMARY

LITEDUO Dental Laser System 510(k) Number K O7 341

Applicant's Name: Light instruments Ltd Tavor Building 1 Yokneam Ind. Zone P.O.Box 223 Yokneam Elite 20692 Tel: (972)4-959-7531 Fax: (972)73-244-2610

Contact Person:	Yoram Levy, Qsite31 Haavoda St.Binyamina, Israel 30500Tel (972)4-638-8837; Fax (972)4-638-0510Yoram@qsitemed.com
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LITEDUO Dental Laser System

Classification: Name: Laser Instrument, Surgical, Powered Product Code: GEX Regulation No: 21 CFR 878.4810 Class: II Panel: General & Plastic Surgery

Device Description:

Trade Name:

The LITEDUO Dental Laser is an advanced microprocessor-controlled laser system, composed of the following units:

. The control panel;
. The Er: Y AG and Diode laser applicators;
High-voltage power supply, capacitor bank and switching module; �
. Diode driver and Diode laser array;
The cooling system;
An Er: YAG laser energy verification module.

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Image /page/1/Picture/0 description: The image shows a logo for a company called "LIGHT DIGITAL IMAGERY". The logo consists of a stylized light or star symbol above the word "LIGHT" in a sans-serif font. Below "LIGHT" are the words "DIGITAL IMAGERY" in a smaller font size. The logo appears to be in black and white.

Intended Use Statement:

The LiteDuo Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.

Er:YAG Laser:

Hard Tissue Indications of Erbium Laser Energy:

Caries removal, Cavity preparation, Enamel etching, Enameloplasty, excavation of pits and fissures for placement of sealant,

Bone Indications of Erbium Laser Energy:

Soft Tissue and Periodontal Indications of Erbium Laser Energy:

Endodontal Indications of Erbium Laser Energy:

Diode Laser:

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hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision and draining of tissue retraction, for impressions, papillectomy, abscesses. vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers. leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Predicate Devices: Substantial equivalence to the following predicate devices is claimed:

Device Name	510k No	Date of approval
LITETOUCH	K061966	27 Sep, 2006
SIROLaser	K053161	18 Jan, 2006
Opus 10	K011769	30 Aug, 2001
Vectra Laser	K060114	7 Apr. 2006

Performance Standards

LITEDUO Dental Laser System complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products.

. In addition, the device complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the following voluntary standards:
. EN 60601-1 (Medical Electrical Equipment-Part 1: General Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
. EN 60825-1 (Safety of laser products);
t EN 60601-2-22 (Medical device equipment, Particular Requirements for the safety and diagnostics and therapeutic laser equipment).
� IEC 60601-1-2 (Electromagnetic compatibility (EMC)

A detailed description appears in Section 14.

Summary of Clinical performance data

The safety and efficacy of Er: YAG Laser devices with wavelength of 2.94 micron and power up to 8.4 Watts, and Diode Laser devices with wavelength of 0.98 micron and power up to 7 Watts are well established

LITEDUO Dental Laser System - 510k Notification

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in scientific research and literature including procedures performed in hard and soft oral tissue, Cosmetic Endodontology and Periodontology.

Due to the comprehensive animal and clinical study performed in scientific research and published in literature, and since the power, wavelength, pulse duration and frequency of the LITEDUO Dental Laser System are well within the previous cleared values, Light Instruments believes that animal and clinical studies are not required to determine the safety and efficacy of the device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2008

Light Instruments Limited % Mr. Yoram Levy Light Instrument QA/RA Consultant Tavor Building 1 Yokneam Ind. Zone P.O. Box 223 Yokneam Elite, Israel 20692

Re: K073411

Trade/Device Name: LITEDUO Dental Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 10, 2008 Received: May 05, 2008

Dear Mr. Levy:

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 such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Yoram Levy

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

LITEDUO Dental Laser System

510(k) Number (if known):

Device Name:

Indications for Use:

The LiteDuo Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.

The LiteDuo Dental Laser System is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue, in oral and maxillofacial surgery and dentistry. In addition, the system is intended for light activation of bleaching materials for teeth whitening.

This includes the following:

Er:YAG Laser:

Hard Tissue Indications of Erbium Laser Energy:

Caries removal, Cavity preparation, Enamel etching, Enameloplasty, excavation of pits and fissures for placement of sealant.

Bone Indications of Erbium Laser Energy:

Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue (bone), Apicoectomy - amputation of the root end. Cutting bone to prepare a window access to the apex (apices) of the root(s), Osseoplasty, Osteotomy, Osseous crown lengthening

Soft Tissue and Periodontal Indications of Erbium Laser Energy:

Excisional and incisional biopsies. Exposure of unerupted teeth, Incision and drainage of abscesses, Gingival incision and excision, Gingivoplasties, Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias, Gingival troughing for crown impressions, Hemostasis, Implant recovery, Frenectomies and frenotomies, Fibromatosis (fibroma removal), malignant lesion removal, Operculectomy, Oral Benign and papillectomies, Reduction of gingival hypertrophy, Soft tissue crown Preprosthetic surgery: flabby alveolar lengthening, ridge. vestibuloplasty, exposure of implants, hyperplasia, epulides, papillomas, fibromatoses benign growths, Vestibuloplasty, Sulcular debridement (removal of diseased or inflamed soft tissue in the

Nilreole fr mkm
(Division Sign-Off)

Division of General, Restorative. and Neurological Devices

510(k) Number K073411

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periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

Endodontal Indications of Erbium Laser Energy:

Diode Laser:

Marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy frenotomy, biopsy, operculectomy, implant recovery, gigngivioplasty, gingival troughing gingivectomy, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision and draining of abscesses, tissue retraction, for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Office of Device Evaluation (ODE) Concurrence of CDRH. (Division Sign-off Division of General, Restorative and Neurological Devices 510(k) Number Ko?"?

LITEDUO Dental Laser System - 510k Notification

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.