The OpusDuo EC Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue.
The Er: YAG laser component is indicated for caries removal, cavity preparation, enamel etching and the, incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacia! surgery and dentistry. These include the following:
Soft tissue and periodontal indications: 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, hyperplasias, epulides, papilomas, 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 Applications: Tooth preparation to obtain access to root canal; Pulpotomy; Pulp extirpation; Pul potomy as an adjunct to root canal therapy; Root canal debridement and cleaning; Root canal preparation including enlargement
The CO2 laser component is indicated for periodontal procedures such as removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement) and vaporization, excision coagulation and ablation of oral soft tissue in procedures such as gingivectorny; frenum release; removal of soft tissue, cysts and tumors.

Device Description

The OpusDuo EC is a model of the Opus 20 Dental Laser System, which is intended to aid during dental procedures performed either in hard or soft oral tissue. This is a dual laser system incorporating an Er:YAG laser and a CO2 laser. The system is operating at a wavelength of 2.94 microns and 10.6 microns respectively. The Er: YAG laser delivers to the tissue pulses with energies up to 1 joule per pulse and power up to 12 Watts. The CO2 laser delivers to the tissue power in continuous mode (CW) up to 10 Watts and pulses (SP) up to 6 Watts.

AI/ML Overview

The provided text is a 510(k) Summary for the OpusDuo EC Dental Laser System, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics. As such, it does not contain the information required to populate a table of acceptance criteria and reported device performance directly from a study.

The document primarily relies on comparing the device's technical characteristics, intended use, and indications for use to previously cleared devices. It states that "The OpusDuo EC intended use and indications for use were previously cleared by FDA for the predicate devices" and that the "technical characteristics... are basically the same as those of the cleared..." predicate devices. It also mentions that "Laser output values of the OpusDuo EC are well within previous cleared values of the predicate devices as described."

The closest the document comes to mentioning performance criteria and validation is:

Performance Standards: The device complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products, and voluntary standards EN 60601-1, EN 60601-1-2, EN-601-2-22, EN-60825-1, CISPR 11: 1997, class B and IEC 61000-4-2/3/4/5: 1995, EMI -EN55011 :1991, IEC 801:1991. These standards cover aspects like electrical safety, electromagnetic compatibility, and laser safety features (interlock protective housing, laser emission indicators, etc.).
Validation Testing: "Validation testing has confirmed that the design of the additional accessories, which are required for the new applications, satisfies their technical specification." This indicates accessory validation, not necessarily the clinical or diagnostic performance of the laser system itself for its stated indications.

Given this context, I cannot generate the requested table and detailed study information as it is not present in the provided text. The document's purpose is to establish substantial equivalence for market clearance, not to detail a clinical performance study with acceptance criteria, ground truth, and expert adjudication.

Summary

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AUG 0 7 2002

510(K) SUMMARY

OPUSDUO EC DENTAL LASER SYSTEM

510(k) Number K O 2150 8

1/4

Applicant's Name:

OpusDent Ltd. Atid Science Based industrial Park, Hagavish 4 St., Natania south P.O.Box 8737 Natania 42505, Israel Tel .: 972-9-892 3333 Fax: 972-9-892 3300

Contact Person:

Dorit Winitz, Ph.D. Push-Med Ltd. 117, Ahuza St., Ra'ananna 43373, Israel Tel: 972-9-7718130 Fax: 972-9-7718131 e-mail: dorit(@push-med.com

Date Prepared:

April 2002

Trade Name:

OpusDuo EC Dental Laser System

Classification Name:

Laser Instrument, Surgical, powered

Classification:

Laser Instrument, Surgical, Powered are class II devices (Product Code GEX),

Predicate Device:

The Opus20/Opus Spectrum/Opus Duo EC Dental Laser System with the additional periodontal, endodontal and soft tissue indications for the Erbium component and the additional periodontal indications for the CO2 component. "OpusDuo EC", is substantially equivalent to the same system (Opus 20 and Opus Spectrum/OpusDuo Dental Laser System) previously cleared for other indications under K002899 and K014100, respectively, in terms of technological characteristics and specifications, mechanism of action and user interface.

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KO21508 2/4

The Erbium component of the OpusDuo EC Dental Laser System with the additional periodontal endodontal and soft tissue indications is substantially equivalent to a combination of the following erbium laser systems cleared by the FDA:

KaVo KEY Laser 1242 (KaVo America Corporation) cleared under -K983100
FuturLase 3000/3002 Erbium Laser System (Pharos Optics, Inc.) cleared under K974641
Pulsemaster Erbium Dental Laser (American Dental technologies, -Inc.) cleared for hard and soft tissues indications under K012127
-Pulsemaster Erbium Dental Laser (American Dental technologies, Inc.) cleared for periodontic indication under K961269
-WaterLase Millennium Dental Laser System (BioLase Technology, Inc.) cleared under KO11041
-WaterLase Millennium Dental Laser System (BioLase Technology, Inc.) cleared for additional endodontic indications under K012511

The CO2 component of the OpusDuo EC with the additional periodontal indications is substantially equivalent to a combination of the Opus 20 and Opus Spectrum/Opus Duo cleared under K002899 and K014100, respectively, the Uni-CO2 450P CO2 Laser System (Medart Corp.), cleared under K991297 and the Opus 10TM Diode Laser (OpusDent Ltd.) cleared under K000990.

Performance Standards:

The OpusDuo EC Dental Laser complies with:

U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products.

In accordance with FDA's guidance "Use of Standards in Substantial Equivalence Determinations", OpusDent is declaring that the OpusDuo EC confirms to EN 60601-1 and EN 60601-1-2.

In addition, the device complies with the voluntary standards, EN-601-2-22, EN-60825-1, CISPR 11: 1997, class B and IEC 61000-4-2/3/4/5: 1995, EMI -EN55011 :1991, IEC 801:1991 as described in Section 5.

In compliance with these standards, OpusDuo EC is equipped with:

Interlock protective housing, laser emission indicators, beam shutters, energy and power display, master key switch, emergency shut-off knob, remote interlock connector and proper labeling.

Intended Use / Indication for Use:

The OpusDuo EC Dental Laser System is intended to aid during dental procedure performed either in hard or soft oral tissue.

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021508 3/4

The Er: YAG laser component is indicated for caries removal, cavity preparation, enamel etching and the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistrv.

The CO2 laser component is indicated for periodontal procedures such as removal of discussed or minuted son used in the periodonitial pointi (suncular debridement) and vaporization, incision, excision, coagulation and ablation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.

Device Description:

Substantial Equivalence:

There are no unique applications, indications, material or specifications presented herein. Evidence of equivalence has been demonstrated through:

· The OpusDuo EC intended use and indications for use were previously cleared by FDA for the predicate devices.
· The technical characteristics of both the Er:YAG and CO2 lasers of the OpusDuo EC system are basically the same as those of the cleared Onus 20 (K002899) and its new model Opus Spectrum/Opus Duo (K014100).

The Er:YAG component of the OpusDuo EC has the same or very similar technical characteristics as its predicates: the KaVo, the FutureLase , the Pulse Master and the WaterLase, including theory of operation, laser medium and the ability to deliver the same wavelength (or very close value, in the case of WaterLase) at a similar average power and pulse rate.

The CO2 component of the OpusDuo EC has the same or very similar technical characteristics including theory of operation, laser medium and the ability to deliver the same wavelength at the same maximal power pulse rate and pulse duration as its predicate device, the Uni-CO2 450P system.

· Laser output values of the OpusDuo EC are well within previous cleared values of the predicate devices as described.
· The predicate devices and other previous cleared lasers with similar energy output have a proven safety and effectiveness in the treatment of the claimed indications.

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· Validation testing has confirmed that the design of the additional accessories, which are required for the new applications, satisfies their technical specification.
Therefore, we believe that the OpusDuo EC Dental Laser System is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues.

Ac イ -

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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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 7 2002

OpusDent Ltd. c/o Dorit Winitz, Ph.D. Push-Med Ltd. 117 Ahuzah Street Ra'ananna, 43373 Israel

Re: K021508 Trade/Device Name: OpusDuo EC Dental Laser System Regulation Number: 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: May 5 2002 Received: May 9, 2002

Dear Dr. Winitz:

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 setforth 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.

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Page 2 - Dr. Dorit Winitz

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Millman

Celia M. Witten, Ph.D., M.D. 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

510(k) Number: K021508

Device Name: OpusDuo EC

Indications for Use:

The OpusDuo EC Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue.

· The Er: YAG laser component is indicated for caries removal, cavity preparation, enamel etching and the, incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacia! surgery and dentistry. These include the following:

Soft tissue and periodontal indications	Endodontal applications
• Excisional and incisional biopsies	• Tooth preparation to obtain access to root canal
• Exposure of unerupted teeth	• Pulpotomy
• Incision and drainage of abscesses	• Pulp extirpation
• Gingival incision and excision	• Pulpotomy as an adjunct to root canal therapy
• Gingivoplasties	• Root canal debridement and cleaning
• Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias	• Root canal preparation including enlargement
• 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, hyperplasias, epulides, papilomas, 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)

· The CO2 laser component is indicated for periodontal procedures such as removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement) and vaporization, excision coagulation and ablation of oral soft tissue in procedures such as gingivectorny; frenum release; removal of soft tissue, cysts and tumors.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over the Counter Use

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.