SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER

K072159 · El.En Electronic Engineering Spa · GEX · Dec 27, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072159
• Device Name: SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER
• Applicant: El.En Electronic Engineering Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The smart CO2 (SmartXide and Smart US20D) Lasers with DOT scanner are indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Device Story

Smart CO2 laser system (SmartXide, Smart US20D) utilizes sealed CO2 gas tube (10.6 um wavelength) for surgical applications. Device includes DOT scanner accessory for ablative skin resurfacing. Operated by physician via footswitch. Laser energy performs incision, excision, ablation, vaporization, and coagulation of soft tissues. System is floor-standing (30 kg, 120x48x55 cm), powered by 115VAC. Clinical benefit includes precise tissue management in various surgical specialties. Output is controlled laser beam; provider uses visual feedback to guide tissue interaction.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Sealed CO2 gas tube laser; 10.6 um wavelength; 115VAC, 15A, 50-60 Hz power; footswitch activation; includes DOT scanner accessory; floor-standing unit.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of soft tissues, including intraoral tissues, across medical specialties including dermatology, plastic surgery, ENT, gynecology, neurosurgery, dental/oral surgery, and genitourinary surgery. Includes ablative skin resurfacing when used with the scanning unit.

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 UltraPulse Encore

Submission Summary (Full Text)

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K072159

## 510(K) Summary

2 7 2007 El En. S.p.A. Submitter: via Baldanzese, 17 50041 Calenzano (FI), Italy Andrea Tozzi Contact: Ouality System Manager & Official Correspondent July, 30, 2007 Date Summary Prepared: Smart CO2 (SmartXide, Smart US20D) with DOT scanner Device Trade Name: Medical Laser System Common Name: Instrument, surgical, powered, laser Classification Name: 79-GEX 21 CFR 878.4810 Equivalent Device: Lumenis UltraPulse Encore and delivery device accessories The Smart CO2 lasers (SmartXide, Smart US20D) are CO2 laser, Device Description: having a sealed CO2 gas tube as the lasing medium. These are lasers with a wavelength of 10.6 um. Laser activation is by a footswitch. Overall weight of the laser is 30 kg, and the size is 120 cm x 48 cm x 55 cm (H x W x D). Electrical requirement is 115VAC, 15A, 50-60 Hz, single phase. The Smart CO2 Lasers are indicated for incision, excision, Intended Use: ablation, vaporization and coagulation of body soft tissues including intraoral tissues. The use with the scanning unit is indicated for ablative skin resurfacing. The Smart CO2 Lasers are substantially equivalent to the Lumenis Comparison: UltraPulse Encore lasers and delivery device accessories . They are both CO2 lasers with a scanning unit as an accessory, for the identical indications for use. Nonclinical Performance Data: None Clinical Performance Data: None Conclusion: The Smart CO2 (SmartXide and Smart US20D) Lasers with DOT scanner are two more safe and effective devices for incision, excision, ablation, vaporization and coagulation of body soft tissue, including intraoral tissue. Additional Information: None

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services USA. The seal features the department's logo, which is a stylized eagle with three lines representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.

Public Health Service

DEC 2 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

El. En. Electronic Engineering S.p.A % Ms. Andrea Tozzi Ouality System Manager Via Baldanzese, 17 50041 Calenzano (FI), Italy

Re: K072159

Trade/Device Name: Smart CO2 (SmartXide, Smart US20D) Laser with DOT scanner Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 08, 2007 Received: November 13, 2007

Dear Ms. Tozzi:

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 - Ms. Andrea Tozzi

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 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 Millhusan

- 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): _K072/S9

Smart CO2 (SmartXide , Smart US20D) Laser with DOT scanner Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The smart CO2 (SmartXide and Smart US20D) Lasers with DOT scanner are indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Prescriptive Use (Part 21 CFR 801 Subpart D)

OR

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

(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bruchard

Division of General. Restorative. and Neurological Devices

**510(k) Number** K072159