SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER

K081181 · Cynosure, Inc. · GEX · May 5, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081181
• Device Name: SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smart US 20 D / UltraSpeed and Smart Clinic laser is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialities of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic liaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications. Also, the Smart CO2 surgical laser is indicated for periodontal applications such as, but not limited to: Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement) Biopsies Frenectomy, Frenum release Gingivoplasty Papillectomy Vestibuloplasty Hyperplasia Operculectomy Drainage (abscess) Flap surgery Fibroma (nonmalignant tumor, mucosa, tongue) Epulis Aphthous ulcers Removal of soft tissue, cysts, and tumors Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium). The PerioPulse laser is indicated for the removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement). It is also indicated for laser assisted new attachment procedure (cementum-medlated periodontal ligment new attachment to the root surface in the absence of long junctional epithelium)

Device Story

Smart CO2 is a CO2 laser system (10.6 um wavelength) utilizing a sealed CO2 gas tube as the lasing medium. Operated via foot switch by clinicians in surgical or dental settings. Device performs incision, excision, ablation, vaporization, and coagulation of soft tissues. Provides therapeutic benefit by enabling precise tissue removal and periodontal procedures, including laser-assisted new attachment. System is a standalone unit (25 kg, 180x62x42 cm) requiring 110 VAC power. Clinicians use the laser output directly on target tissue to achieve surgical goals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

CO2 gas laser; 10.6 um wavelength; 110 VAC, 15A, 50-60 Hz power; 25 kg weight; 180x62x42 cm dimensions; foot switch activation.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, ablation, vaporization, or coagulation across various surgical specialties including general, plastic, oral/maxillofacial, dental, dermatological, endoscopic, gastroenterological, gynecological, ENT, neurosurgical, oculoplastic, orthopedic, pulmonary/thoracic, and urological procedures. Includes specific periodontal applications like sulcular debridement, biopsies, frenectomy, gingivoplasty, and laser-assisted new attachment 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

• Lumenis OpusDent Family laser
• Millennium Dental Technologies PerioLase Dental Laser

Submission Summary (Full Text)

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K081181

## 510(K) Summary

MAY - 5 2008 Cynosure, Inc. Submitter: 5 Carlisle Road Westford, MA 01886 Contact: George Cho Senior Vice President of Medical Technology Date Summary Prepared: April 24, 2008 Device Trade Name: Smart CO2 Common Name: Medical Laser System Classification Name: Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810 Equivalent Device: Lumenis OpusDent Family laser and Millennium Dental Technologies PerioLase Dental Laser Device Description: Smart CO2 is a CO2 laser, having a sealed CO2 gas tube as the lasing medium. It is a laser with a wavelength of 10.6 um. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase. Intended Use: The Smart CO2 laser is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues. It is also indicated for laser assisted new attachment procedure. Comparison: The Smart CO2 laser is substantially equivalent to the predicate devices. Thet have the same principle of operation and essentially the same power range and the same 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 tissue, including intraoral soft tissue applications. Additional Information: none

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2008

Cynosure, Inc. % Mr. George Cho Sr. VP, Medical Technology 5 Carlisle Road Westford, Massachusetts 01886

Re: K081181 Trade/Device Name: Smart CO2 ((Smart US 20 D / UltraSpeed, Smart Clinic and PerioPulse) 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, 2008 Received: April 25, 2008

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

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Page 2 - Mr. George Cho

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark N. Milken

Mark N. Melkerson 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): K081181

## Device Name: Smart CO2 ((Smart US 20 D / UltraSpeed, Smart Clinic and PerioPulse) Laser

Indications For Use:

The Smart US 20 D / UltraSpeed and Smart Clinic laser is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialities of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology,

endoscopic liaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.

Also, the Smart CO2 surgical laser is indicated for periodontal applications such as, but not limited to:

Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular A

debridement)

Biopsies A

Frenectomy, Frenum release

Gingivoplasty

Papillectomy

ﺮ Vestibuloplasty

ア Hyperplasia

♪ Operculectomy

ア Drainage (abscess)

> Flap surgery

> Fibroma (nonmalignant tumor, mucosa, tongue)

> Epulis

> Aphthous ulcers

Removal of soft tissue, cysts, and tumors >

Laser assisted new attachment procedure (cementum-mediated periodontal ligament > new-attachment to the root surface in the absence of long junctional epithelium).

The PerioPulse laser is indicated for the removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement). It is also indicated for laser assisted new attachment procedure (cementum-medlated periodontal ligment new attachment to the root surface in the absence of long junctional epithelium)

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Defice Evaluation (ODE)

Nek

Crossion Sign-Off Dision of General, Restorative, and Neurological Devices

510(k) Number K041141