OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND

K014100 · Opusdent , Ltd. · GEX · Jan 8, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014100
• Device Name: OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
• Applicant: Opusdent , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OpuDuo 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, and enamel etching. The CO2 laser component is indicated for vaporization, incision, excision and coagulation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.

Device Story

Dual-wavelength dental laser system (Er:YAG 2.94 microns; CO2 10.6 microns) for hard and soft oral tissue procedures. Er:YAG delivers pulses up to 1J/pulse and 12W; CO2 delivers continuous wave up to 10W or pulses up to 6W. Operated by dental professionals in clinical settings. System features PC-based control (PCM-5820) with touch-screen interface, replacing embedded CPU and soft keys of predecessor. Includes online power monitoring for Er:YAG, dual-mast delivery system, and microswitch-based handpiece identification for safety. External cooling system manages internal thermal loads. Output used by clinicians to perform precise tissue ablation, coagulation, and excision. Benefits include improved ergonomics, enhanced safety via handpiece correlation, and real-time power monitoring.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities were performed based on risk analysis to confirm the safety and performance of the modified design features.

Technological Characteristics

Dual-laser system (Er:YAG 2.94 microns, CO2 10.6 microns). PC-controlled (PCM-5820) with touch-screen interface. Features: online power monitoring, dual-mast delivery, microswitch handpiece safety interlocks, external cooling system. Software runs on Windows NT. Smaller form factor and reduced weight compared to predicate.

Indications for Use

Indicated for dental patients requiring hard tissue procedures (caries removal, cavity preparation, enamel etching) or soft tissue procedures (vaporization, incision, excision, coagulation, gingivectomy, frenum release, removal of cysts/tumors).

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

• Opus 20 dental laser system (K002899)

Submission Summary (Full Text)

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## 510(k) Summary

## OpusDent Ltd.

## Opus Spectrum

510(k) Number KO 14/00

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## Submitter's Name:

OpusDent Ltd. Atid Science Based industrial Park, Hagavish 4 St., Natania south P.O.Box 8737 Natania 42505, Israel Tel .: [phone] Fax: [phone]

## Contact Person:

Arava Hacohen Push-Med Ltd. 117, Ahuza St., Ra'ananna 43373, Israel Tel: [phone] Fax: [phone] e-mail: [e-mail]

## Trade Name:

Opus Spectrum (a model of Opus 20)

## Classification Name:

Laser Instrument, Surgical, Powered

#### Classification:

t

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

#### Predicate Device:

The Opus Spectrum dental laser system is substantially equivalent to Opus 20 dental laser system (OpusDent Ltd, Israel) cleared under K002899.

## Indication for use:

The OpuDuo 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, and enamel etching.

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43 K014160

The CO2 laser component is indicated for vaporization, excision and coagulation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.

## Device Description:

The Opus Spectrum c is a model of the Opus 20 Dental Laser System which is intended to aid during dental procedure performed either in hard or soft oral tissue. This is a dual laser system incorporating an Er: Y AG 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.

## Substantial Equivalence:

The Opus Spectrum dental laser system is substantially equivalent to the Opus 20 dental laser system (OpusDent Ltd.). In fact, it is an improved model of Opus 20 that is similar to its predicate device except the following features:

- · Opus Spectrum software runs on Window NT® Operating System while Opus 20 incorporates a stand-alone software.
- · Opus Spectrum is controlled by a PC Computer (PCM-5820) while Opus 20 is controlled by an embedded CPU.
- · Opus Spectrum has a Touch-Screen technology instead of soft keys.
- · Opus Spectrum incorportes an On Line Monitor that monitors the Er:YAG lasing power in addition to the two power meters in Opus 20.
- · Opus Spectrum has two masts one for Er:YAG and one for CO2. Opus 20 has one mast for both lasers.
- · Additional safety feature was added to Opus Spectrum. A microswitch is located in each handpiece carrier to indicate the handpiece in use and to identify miscorrelation between handpiece and desired laser mode.
- · Opus Spectrum has external cooling system that cools the coolant of the internal cooling systems while Opus 20 has internal water/air cooling system.
- · Opus Spectrum incorporates a new power supply.
- · Opus Spectrum is smaller in size and it is half weight than Opus 20.
- · The external design of the Opus Spectrum differs from Opus 20.

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K014/00 3/3

# Design Control Activities Summary:

The risk analysis methods used to assess the impact of the modification on the device and its components, and the result of the analysis are presented in Section 4 of the submission.

Based on the risk analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied are presented in Sections 6 and 8 of this submission.

A declaration of conformity with design control is attached to Section 6 of this submission.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird, possibly an eagle, with its wings spread.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 8 2002

OpusDent Ltd. c/o Mr. Arava Hacohen Project Manager Push-med Ltd. 117 Ahuza Street Ra'ananna 43373 Israel

Re: K014100 Trade/Device Name: Opus Spectrum Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: November 19, 2001 Received: December 13, 2001

Dear Mr. Hacohen:

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 - Mr. Arava Hacohen

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

StipA. Rhodes

Julie M. Witten, Ph.D., M.D.

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

014100

Opus Spectrum Device Name:

Indications for Use:

The OpuDuo 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, and enamel etching.

The CO2 laser component is indicated for vaporization, incision, excision and coagulation of oral soft tissue in procedures such as gingivectomy; 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)

Thypt Church

(Division Sign-Off) Division of General, Restorative and Neurological Devices

Prescription Use
(Per 21 CFR 801.109)

510(k) Number K014100
OR Over the Counter Use