The Erbium: Y AG laser 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. This includes the following:

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)
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

Device Description

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

Control panel
Laser accessory, including the Erbium laser assembly and water spray equipment
High-voltage power supply, capacitor bank and switching module
Cooling unit
Tip power detection module

AI/ML Overview

The provided text is a 510(k) summary for the LITETOUCH Dental Laser System. It focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards rather than presenting a study with acceptance criteria and device performance metrics in the way one might find for a diagnostic or AI-driven medical device.

Therefore, many of the requested details about acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, expert qualifications, and ground truth establishment are not applicable or available in this document.

Here's an analysis based on the provided text, highlighting what is and isn't available:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The document states that the device "complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products" and other international standards (EN 60601-1, EN 60825-1, etc.). While these standards define criteria for performance and safety, the document does not present them as "acceptance criteria" for a specific study comparing the device's measured performance against those criteria. It asserts compliance but doesn't detail the performance metrics or the specific ranges that would constitute "acceptance."

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

This information is not applicable/provided. The document explicitly states: "Due to the comprehensive animal and clinical study performed in scientific research and literature, and since the power, wavelength, pulse duration and frequency of the LITETOUCH 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 means no new "test set" of data was generated or used for a specific clinical or performance study of this device. The submission relies on existing scientific literature and the established performance of similar predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable/provided for the reasons stated above (no new test set, reliance on literature).

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

This information is not applicable/provided for the reasons stated above (no new test set, reliance on literature).

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

This information is not applicable/provided. The LITETOUCH Dental Laser System is a physical medical device (a laser system) for direct dental procedures, not a diagnostic or AI-powered imaging device that would involve "human readers" or AI assistance in interpretation.

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

This information is not applicable/provided. As above, this is a physical laser device, not an algorithm.

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

This information is not applicable/provided in the context of a specific study for this device. The "ground truth" for its safety and efficacy is considered to be established by the "comprehensive animal and clinical study performed in scientific research and literature" for similar Er:YAG laser devices. This implies that the effectiveness of this type of laser for its indicated uses (e.g., caries removal, soft tissue incision) has been independently validated by general medical and dental research, likely through various methods including clinical outcomes, pathological examination where relevant, and expert consensus over time.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable/provided. There is no "training set" as this is not an AI/machine learning device.

Summary of Device and Study (as presented in the 510(k) Summary):

Device: LITETOUCH Dental Laser System (Erbium:YAG laser)
Intended Use: Aid during dental procedures in oral and maxillofacial surgery and dentistry, covering hard tissue (tooth and bone) and soft tissue applications, including endodontal and periodontal indications.
Predicate Devices: OpusDent Family of Dental Laser Systems (K040270) and Hoya ConBio VersaWave™ Dental Er:YAG Laser System (K041710).
Basis for Substantial Equivalence: The manufacturer asserts that the safety and efficacy of Er:YAG laser devices with similar specifications (2.94 micron wavelength, power up to 8.5 Watts) are "well established in scientific research and literature." They argue that because the LITETOUCH's power, wavelength, pulse duration, and frequency are "well within the previous cleared values," new animal or clinical studies are not required.
Compliance: The device complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products, as well as European Medical Directive 93/42/EEC and specific EN/IEC/CISPR standards related to medical electrical equipment, laser safety, and EMC.

In essence, this 510(k) relies on the well-established safety and efficacy of the technology (Er:YAG lasers) and demonstrates that the LITETOUCH device adheres to relevant performance and safety standards, making it substantially equivalent to previously cleared devices. It does not present a de novo clinical study with specific acceptance criteria that the device's measured performance statistically met.

Summary

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SEP 2 7 2006

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510(K) SUMMARY

LITETOUCH Dental Laser System 510(k) Number K_0619b6

Applicant's Name:	Light instruments Ltd
	1 Ha'oman St.
	Binyamina, 30500
	P.O.B. 168, Israel
Tel:	(972)4-618-1151
Fax:	(972)57-794-4975

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

Trade Name: LITETOUCH Dental Laser System

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

Device Description:

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

. Control panel
Laser accessory, including the Erbium laser assembly and water spray . equipment
High-voltage power supply, capacitor bank and switching module .
Cooling unit ●
Tip power detection module .

LITETOUCH Dental Laser System - 510k Notification

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Image /page/1/Picture/0 description: The image shows the logo for "light instruments". The word "light" is written in a bold, sans-serif font, with the "i" dotted with a circle. Below "light", the word "instruments" is written in a smaller, lighter font. The logo is simple and modern.

Intended Use Statement:

The LITETOUCH dental laser system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.

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) .
Benign and malignant lesion removal
Operculectomy .
Oral papillectomies .

LITETOUCH Dental Laser System -- 510k Notification

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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

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

OpusDent Family of DentalLaser Systems	K040270	Decision Date: 12/16/2004
Hoya ConBio VersaWave™Dental Er:YAG Laser System	K041710	Decision Date: 08/03/2004

Performance Standards

LITETOUCH 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); .
EN 60601-2-22 (Medical device equipment, Particular Requirements . for the safety and diagnostics and therapeutic laser equipment).
. CISPR 11 (EMC),
IEC 61000-4-2/3/4/5 (Electromagnetic compatibility (EMC) -.

LITETOUCH Dental Laser System - 510k Notification

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light

Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test,

EN55011 and IEC 801-2 .
A detailed description appears in Section 14.

Summary of Clinical performance data

The safety and efficacy of Er: Y AG Laser devices with wavelength of 2.94 micron and power up to 8.5 Watts is well established in scientific research and literature including procedures performed in hard and soft oral tissue, Endodontology and Periodontology.

Due to the comprehensive animal and clinical study performed in scientific research and literature, and since the power, wavelength, pulse duration and frequency of the LITETOUCH 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is left-aligned and in a simple, sans-serif font.

SEP 2 7 2006

Light Instruments Ltd. % Osite Yoram Levy General Manager 31 Haavoda Street Binyamina, Israel 30500

Re: K061966

Trade/Device Name: LITETOUCH 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: July 9, 2006 Received: July 12, 2006

Dear Yoram Levy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bocken on (t) [e device is substantially equivalent (for the indications for referenced above and have asseming marketed predicate devices marketed in interstate commerce use stated in the enactment date of the Medical Device Amendments, or to devices that prov to May 20, 1770, and cordance with the provisions of the Federal Food, Drug, and Cosmetic Ilave occh recuire approval of a premarket approval application (PMA). You may, Act (Act) market the device, subject to the general controls provisions of the Act. The general therefore, mance the device, barrest examinents for annual registration, listing of devices, good controls provisions or a.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 If your device is elassified (600 as notrols. Existing major regulations affecting your device can may be subject to sublemal econlations, 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 I has be advised that I Dr . . Hosaanse explice complies with other requirements of the Act mat 117A has made a docemmation and ministered by other Federal agencies. You must comply or any I caerar starter. and regulation ing, but not limited to: registration and listing (21 CFR Part with an the rece 7 referent 801); good manufacturing practice requirements as set forth in the

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Page 2 - Yoram Levy

quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product quality Systems (QS) roggins (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) I mis letter with and in yourse of substantial equivalence of your device to a legally premaired 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 11 you desire spocente ad (240) 276-0115. Also, please note the regulation entitled, eoniaer the Office of Company of Compress to tification" (21CFR Part 807.97). You may obtain other whoolulunding of responsibilities under the Act from the Division of Small general 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 yours,

R of
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

0619 510(k) Number (if known):

ANSBOUCH Dental Laser System 2000 Device Name: ------

Indications for Use:

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

The LITETOUCH 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. This includes the following:

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

LITETOUCH Dental Laser System - 510k Notification

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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) .
Benignand 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 .

Use X Prescription (Part 21 CFR 801 Subpart D)

(Division Sign-off)

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

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

Concurrence of CDRH, Office of Device Evaluati Di (ABRE) S

Division of Ceneral, Restorative,

(Division of General & Plastic Surgery Devices and Neurological Devices 510(k) Number

2-510(k) Number K061966

LITETOUCH 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.