SMARTXIDE

K031224 · Cynosure, Inc. · GEX · May 9, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031224
• Device Name: SMARTXIDE
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smart CO2 surgical lasers are indicated for incision, and coagulation of body soft tissue. It's typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology and general surgery.

Device Story

Smart CO2 is a medical laser system utilizing a sealed CO2 gas tube as the lasing medium; emits 10.6 μm wavelength laser energy. Device activation controlled via foot switch. System dimensions 180x62x42 cm; weight 25 kg. Operated by clinicians in clinical settings for soft tissue surgical applications. Laser energy interacts with tissue to perform incision, excision, and coagulation. Benefits include precise tissue management during surgical procedures.

Clinical Evidence

No clinical data provided; no nonclinical performance data provided.

Technological Characteristics

Sealed CO2 gas tube lasing medium; 10.6 μm wavelength; 110 VAC, 15A, 50-60 Hz power requirement; foot switch activation; 180x62x42 cm form factor; 25 kg weight.

Indications for Use

Indicated for incision, excision, and coagulation of body soft tissue in patients undergoing procedures in dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology, and general surgery.

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

• PhotoAppeal laser

Submission Summary (Full Text)

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K 031224

:

MAY - 9 2003

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: | April 16, 2003 |
| Device Trade Name: | Smart CO₂ |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.4810 |
| Equivalent Device: | PhotoAppeal laser |
| Device Description: | Smart CO₂ is a CO₂ laser, having a sealed CO₂ gas tube as the lasing<br>medium. It is a laser with a wavelength of 10.6 μm.<br><br>Laser activation is by foot switch. Overall weight of the laser is 25<br>Kg, and the size is 180x62x42 cm (HxWxD).<br><br>Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | The Smart CO₂ laser is indicated for incision, excision, and<br>coagulation of body soft tissue. |
| Comparison: | The Smart CO₂ laser is substantially equivalent to the PhotoAppeal<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 CO₂ laser is another safe and effective device for body soft<br>tissue 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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, represented by curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY = 9 2003

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

Re: K031224

Trade/Device Name: Smart CO2 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 16, 2003 Received: April 23, 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 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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03 1224 510(k) Number (if known):

Device Name: Smart CO2 (Smart US 20D, Smart Clinic) Laser

Indications For Use:

The Smart CO2 surgical lasers are indicated for incision, and coagulation of body soft tissue. It's typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology and general surgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

eral. Restorative Division of Ge and Neurological Levices

510(k) Number K031224

Prescription Use

OR