CYNOSURE SMART 2940D ER:YAG LASER

K031389 · Cynosure, Inc. · GEX · Oct 1, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031389
• Device Name: CYNOSURE SMART 2940D ER:YAG LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smart 2940D Er:YAG Laser system is indicated to be used for ablation, incision, excision, vaporization and coagulation of hard and soft intraoral tissue. The procedures include caries removal, cavity preparation and enamal etching.

Device Story

Smart 2940D is an Er:YAG laser system (2,940 nm wavelength) utilizing an Er:YAG crystal rod as the lasing medium. Operated by a clinician via footswitch, the device is used in dental settings for intraoral hard and soft tissue procedures. The laser energy is applied directly to tissue to perform ablation, incision, excision, coagulation, and vaporization. By providing precise tissue interaction, the device facilitates caries removal, cavity preparation, and enamel etching, offering a surgical alternative to traditional dental instruments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Er:YAG laser system; 2,940 nm wavelength; Er:YAG crystal rod lasing medium; footswitch activation; 47 kg weight; 145x23x65 cm dimensions; 230 VAC, 15A, 50-60 Hz power requirement.

Indications for Use

Indicated for patients requiring ablation, incision, excision, vaporization, and coagulation of hard and soft intraoral tissue, including caries removal, cavity preparation, and enamel etching.

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

• Fotona Fidelis
• American Dental Technologies Pulsemaster Er:YAG

Submission Summary (Full Text)

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## 510(K) Summary

| Submitter: | Cynosure, Inc.<br>10 Elizabeth Drive<br>Chelmsford, MA 01824 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | May 1, 2003 |
| Device Trade Name: | Smart 2940D Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device: | Fotona Fidelis & American Dental Technologies Pulsemaster Er:Y:YAG |
| Device Description: | Smart 2940D is a Er:YAG laser, having a Er:YAG crystal rod as the<br>lasing medium. It is a laser with a wavelength of 2,940 nm. |
| | Laser activation is by footswitch. Overall weight of the laser is 47 Kg,<br>and the size is 145x23x65 cm (HxWxD). |
| | Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | The Smart 2940D is indicated for ablation, incision, excision,<br>coagulation and vaporization of intraoral hard and soft tissue. |
| Comparison: | The Smart 2940D laser has an equivalent indication for uses, the same<br>principle of operation, the same wavelength and essentially the same<br>pulse energy range as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Smart 2940D laser is another safe and effective device for<br>intraoral hard and soft tissue applications. |
| Additional Information: | none |

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OCT - 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031389 Trade/Device Name: Smart 2940D 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: August 15, 2003 Received: August 18, 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 cither 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 (OS) 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]. 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

for 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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<031380 510(k) Number (if known):

Device Name: _Cynosure Smart 2940D Laser

Indications For Use:

The Smart 2940D Er:YAG Laser system is indicated to be used for ablation, incision, excision, vaporization and coagulation of hard and soft intraoral tissue.

The procedures include caries removal, cavity preparation and enamal etching.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K031389

Prescription Use

OR