The OpusDent Family of Er:YAG and CO2/Er:YAG Combination Laser Products (and the delivery accessories that are used with them to deliver laser energy) are intended for use in dental procedures performed in oral and maxillofacial surgery and dentistry.

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

The Er: YAG laser component 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 dentisty.

This includes the following:

Hard Tissue Indications of Er:YAG Laser Energy

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

Bone Indications of Er:YAG Laser Energy

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

Soft Tissue and Periodontal Indications of Er: YAG Laser Energy

Excisional and incisional biopsies
Exposure of unerrupted 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, papilomas, fibromatoses, benign growths
Vestibuloplasty
Sucular 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 of Er: YAG 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

The CO2 laser component is indicated for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in a variety of soft tissue applications, and in oral and maxillofacial surgery and dentistry.

Periodontal Applications of CO2 Laser Energy:

Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement)
Biopsies
Frenectomy, Frenum release
Gingivectomy
Gingivoplasty
Papillectomy
Vestibuloplasty
Hyperplasia
Operculectorny
Drainage (abscess)
Flap surgery
Fibroma (nonmalignant tumor; mucosa, tongue)
Epulis (tumor of the gum)
Aphthous ulcers
Removal of soft tissue, cysts, and tumors

Device Description

The OpusDent Family of Dental Laser Systems is comprised of the following main components:

A light/ laser system console (including software and control electronics) with a control and display panel;
Delivery devices; and
One or more attached hand-piece(s).

AI/ML Overview

The provided document is a 510(k) summary for the OpusDent Family of Dental Laser Systems. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a performance study against a defined ground truth.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

Acceptance criteria table and reported performance: Not available. The submission focuses on substantial equivalence to predicate devices, not on quantitative performance metrics.
Sample size and data provenance for a test set: Not applicable as a performance study in this context is not described.
Number of experts and their qualifications for ground truth: Not applicable.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is not found in the document.
Standalone algorithm performance: Not applicable. The device is a laser system, not an AI algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How ground truth for the training set was established: Not applicable.

The document states that "Review of indications for use and technical characteristics and data provided were used to support the safety and effectiveness and substantial equivalence of the OpusDent Family of Er YAG and CO2/Er.YAG Combination Laser Products". However, it does not detail specific studies or data that would allow for filling out the requested table or answering the specific questions about performance criteria and study methodology.

Summary

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DEC 1 € 2004

A. 510(k) Summary	K040270
General Information
Submitter:	Lumenis, Inc.2400 Condensa StreetSanta Clara, CA 950511
Contact Person:	Karen L Baker/ Martha Murari, PhD
Summary Preparation Date:	December 2004

Names
Device Names:	OpusDent Family of Dental Laser Systems
Primary Classification Names:	Surgical Powered Laser Instrument

III. Predicate Devices

II.

and the contraction of the country

OpusDent Duo, OpusDent 20, and OpusDent Spectra (K021508) .
Stryker Total Performance System (TPS) (K032117 and K991696) .
Hoya Conbio VersaWave Dental Er:YAG Laser System (K041710) .

IV. Product Description

The OpusDent Family of Dental Laser Systems is comprised of the following main components:

A light/ laser system console (including software and control electronics) with a . control and display panel;
Delivery devices; and .
. One or more attached hand-piece(s).

V. Intended Use and Indications for Usc

Intended Use: The OpusDent Family of Er:YAG and CO2/Er:YAG Combination Laser Products (and the delivery accessories that are used with them to deliver laser energy) are intended for use in dental procedures performed in oral and maxillofacial surgery and dentistry.

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VI. Rationale for Substantial Equivalence

The OpusDent Family of Er:YAG and CO2/Er:YAG Combination Laser Products (and the delivery accessories that are used with them to deliver laser energy) share the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore are substantially equivalent for use in general and plastic surgery, and dentistry for surgical applications to the predicate OpusDent Duo, OpusDent 20, and OpusDent Spectra (K021508), the Stryker Total Performance System (TPS) (K03217 and K991696), and the Hoya Conbio VersaWave Dental (173) (K63217)
(K041710) (K041710).

VII. Safety and Effectiveness Information

Review of indications for use and technical characteristics and data provided were used to support the safety and effectiveness and substantial equivalence of the OpusDent Family of Er YAG and CO2/Er.YAG Combination Laser Products for use in specific applications in the medical specialties of general and plastic surgery, and dentistry.

VIII. Conclusion

The OpusDent Family of Er: YAG and CO2/Er: YAG Combination Laser Products (and the delivery accessories that are used with them to deliver laser energy) was found to be Spectre, (K031509) the Stephent OpusDent Duo, OpusDent 20, and OpusDent 20, and OpusDent Spectra (KO21508), the Stryke Total Performance System (TPS) (KO32117 and K991696), and the Hoya Conbio VersaWave Dental Er: YAG Laser System (K041710).

The OpusDent Family of Er: YAG and CO2/Er: YAG Combination Laser Products (and the delivery accessories that are used with them to deliver laser energy) shares the same indications for use, and similar design features, and functional features, and thus are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2004

Lumenis, Inc. c/o Ms. Ann Worden Consultant 3637 Bernal Avenue Pleasanton, California 94566

Re: K040270 Trade/Device Name: Opus Dent Family of Dental Lasers 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: November 16, 2004 Received: November 17, 2004

Dear Ms. Worden:

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 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.

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Page 2 - Ms. Ann Worden

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C Provost

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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510(k) Number (if known): K040270

Device Name: OpusDent Family of Dental Laser Systems

Indications for Use:

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

This includes the following:

Hard Tissue Indications of Er:YAG Laser Energy

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

Bone Indications of Er: Y AG Laser Energy

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

*** Continued on the Following Page ***

Prescription Use > (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provoost

Division of General, Restorative, and Neurological Devices

Page_1 of 3

LUMENIS, INC.
MODIFICATION TO ER: 510(k) Number	K040270
	MBINATION PRODUCT FAMILIES

243 Page Revised December 2, 2004

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510(k) Number (if known): K040270

Device Name: OpusDent Family of Dental Laser Systems

Indications for Use: *** Continued from Previous Page ***

Soft Tissue and Periodontal Indications of Er: YAG Laser Energy

. Excisional and incisional biopsies
Exposure of unerrupted teeth .
Incision and drainage of abscesses .
Gingival incision and excision .
t Gingivoplasties
Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of t 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, papilomas, fibromatoses, benign growths
. Vestibuloplasty
Sucular 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)

*** Continued on the Following Page ***

Prescription Use > (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 3

LUMENIS, INC. MODIFICATION TO ER: YAG AND CO₂/ER:Y AG COMBINATION PRODUCT FAMILIES

244 Page Revised December 2, 2004

{6}------------------------------------------------

510(k) Number (if known): K040270

Device Name: OpusDent Family of Dental Laser Systems

Indications for Use: *** Continued from Previous Page ***

Endodontal Applications of Er: YAG Laser Energy:

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

Periodontal Applications of CO2 Laser Energy:

Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement) �
Biopsies .
Frenectomy, Frenum release .
. Gingivectomy
Gingivoplasty
Papillectomy #
. Vestibuloplasty
Hyperplasia ●
Operculectorny �
Drainage (abscess) .
Flap surgery �
Fibroma (nonmalignant tumor; mucosa, tongue) .
Epulis (tumor of the gum) ●
Aphthous ulcers ●
Removal of soft tissue, cysts, and tumors .

Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 3 of

LUMENIS, INC. MODIFICATION TO ER: YAG AND CO₂/ER: Y AG COMBINATION PRODUCT FAMILIES

245 Page Revised December 2, 2004

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.