SMART 2940 D ER: YAG LASER

K031317 · Cynosure, Inc. · GEX · May 22, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031317
• Device Name: SMART 2940 D ER: YAG LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smart 2940 D laser is indicated for intraoral soft tissue surgery including dental soft tissue.

Device Story

Smart 2940 D is an Er:YAG laser system used for intraoral soft tissue surgery. The device utilizes a flashlamp-pumped Erbium rod as the lasing medium to generate a 2,940 nm wavelength laser beam. Operated by a clinician via a foot switch, the system is designed for use in a clinical setting. The laser energy is applied to soft tissue to perform surgical procedures. The device is a standalone unit weighing 25 kg with dimensions of 180x62x42 cm, powered by 110 VAC. It functions similarly to existing medical laser systems for soft tissue applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Er:YAG laser; flashlamp-pumped Erbium rod; 2,940 nm wavelength; 110 VAC, 15A, 50-60 Hz power; foot switch activation; 25 kg weight; 180x62x42 cm dimensions.

Indications for Use

Indicated for patients requiring intraoral soft tissue surgery, including dental soft tissue procedures.

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

• PhotoDent laser

Submission Summary (Full Text)

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## 510(K) Summary <0313/7

## MAY 2222003

| Submitter: | Cynosure, Inc.<br>10 Elizabeth Drive<br>Chelmsford, MA 01824 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | April 24, 2003 |
| Device Trade Name: | Smart 2940 D laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device: | PhotoDent laser |
| Device Description: | Smart 2940 D is an Er:YAG laser, having a flashlamp pumped,<br>Erbium rod as the lasing medium. It is a laser with a wavelength of<br>2,940 nm. |
| | Laser activation is by foot switch. Overall weight of the laser is 25<br>Kg, and the size is 180x62x42 cm (HxWxD).<br>Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | The Smart 2940 D laser is indicated for intraoral soft tissue surgery. |
| Comparison: | The Smart 2940 D laser is substantially equivalent to the PhotoDent<br>laser, with the same principle of operation, the same wavelength and<br>essentially the same power range as the predicate devices for the same<br>indications for uses. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Smart 2940 D laser is another safe and effective device for soft<br>tissue surgery applications. |
| Additional Information: | none |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted with three parallel lines forming the wings and a flowing design for the body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 22 2003

Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824

Re: K031317 Trade/Device Name: Smart 2940 D Laser 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: April 24, 2003 Received: April 25, 2003

Dear Mr. Cho:

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. George Cho

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]. 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) you may obtain. 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 vours.

Mark n Milkin

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): < 0 3/3/ 7

Device Name: Smart 2940 D Laser

Indications For Use:

The Smart 2940 D laser is indicated for intraoral soft tissue surgery including dental soft tissue.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mckinnon
Division Sign Off

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

10(k) Number K031317

Over-The-Counter Use_