OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM

K040270 · Lumenis, Ltd. · GEX · Dec 16, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040270
• Device Name: OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM
• Applicant: Lumenis, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

OpusDent Family of Dental Laser Systems consists of a console with control electronics/software, delivery accessories, and hand-pieces. Device utilizes Er:YAG and CO2 laser energy to perform incision, excision, cutting, ablation, vaporization, and coagulation of oral hard and soft tissues. Operated by dental professionals in clinical settings. Laser energy delivered via hand-piece to target site; clinician controls parameters via console panel. Output allows for precise tissue removal, bone contouring, and periodontal/endodontal treatment. Benefits include minimally invasive surgical access, improved hemostasis, and efficient tissue management compared to traditional mechanical instruments.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, comparison of technical characteristics, and established indications for use consistent with predicate devices.

Technological Characteristics

System comprises laser console, delivery accessories, and hand-pieces. Energy source: Er:YAG and CO2 lasers. Function: surgical laser instrument for hard/soft tissue. Connectivity: standalone console with integrated control electronics and software. Sterilization: delivery accessories are typically reusable/sterilizable. Software: embedded control system for laser parameters.

Indications for Use

Indicated for dental patients requiring hard tissue (tooth/bone) procedures, soft tissue surgery, and endodontal therapy. Hard tissue: caries removal, cavity prep, enamel etching/plasty, bone cutting/resection, apicoectomy, osseous crown lengthening, osteotomy. Soft tissue: biopsies, abscess drainage, gingivectomy/plasty, frenectomy, implant recovery, lesion removal, sulcular debridement. Endodontal: root canal access, pulpotomy, pulp extirpation, root canal debridement/prep. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

• 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)

Submission Summary (Full Text)

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# DEC 1 € 2004

| A. 510(k) Summary | K040270 |
|-------------------------------|-----------------------------------------------------------------|
| General Information | |
| Submitter: | Lumenis, Inc.<br>2400 Condensa Street<br>Santa 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

I.

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 [phone]. 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 [phone] or [phone] 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.

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: 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

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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 ***

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

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 .

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