(77 days)
Not Found
No
The document describes a microprocessor-controlled laser system for dental procedures and does not mention any AI or ML capabilities.
Yes
The device is intended for various dental and oral surgical procedures, which directly involve treating medical conditions and restoring health by modifying body structure or function.
No
Explanation: The LITETOUCH dental laser system is described as being "intended to aid during dental procedures" and its indications for use focus on "incision, excision, cutting, ablation, vaporization, and coagulation" of tissue, as well as "caries removal," "cavity preparation," and "root canal debridement." These are all therapeutic or procedural actions, not diagnostic ones. The text does not mention any function for identifying or analyzing medical conditions.
No
The device description clearly outlines multiple hardware components including a control panel, laser accessory, power supply, cooling unit, and tip power detection module. 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:
- Intended Use: The intended use clearly describes the device as a dental laser system used for performing procedures directly on patients' oral and maxillofacial tissues (hard and soft). This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details the components of a laser system designed for delivering energy to tissue. It does not mention any components or functions related to analyzing biological samples (like blood, urine, or tissue samples) outside of the body.
- Lack of IVD Characteristics: The description and intended use do not align with the definition of an IVD, which is a device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, disease or congenital abnormality.
The LITETOUCH dental laser system is a medical device used for treatment and surgical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The LITETOUCH dental laser system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.
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
Product codes
GEX
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and maxillofacial
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 2 7 2006
Image /page/0/Picture/1 description: The image shows the word "light" in a bold, sans-serif font. Below the word "light" is a smaller text that is difficult to read due to the image quality. The word "light" is the most prominent feature of the image.
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, Qsite
31 Haavoda St.
Binyamina, Israel 30500
Tel (972)4-638-8837; Fax (972)4-638-0510
Yoram@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
1
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.
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 .
LITETOUCH Dental Laser System -- 510k Notification
2
- 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 Dental
| Laser 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
3
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.
4
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
5
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
6
Image /page/6/Picture/0 description: The image shows the logo for "light instruments". The word "light" is in bold, black, lowercase letters. Below "light" is the word "instruments" in a smaller, lighter font.
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
7
- 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