EXELO2, MODEL 4010

K090639 · Quantel Derma GmbH · ONG · Oct 29, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090639
• Device Name: EXELO2, MODEL 4010
• Applicant: Quantel Derma GmbH
• Product Code: ONG · General, Plastic Surgery
• Decision Date: Oct 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EXELO2 with the fractional scanning unit is indicated for ablative skin resurfacing in people with skin types 1, 2 or 3 based on Fitzpatrick skin type scale.

Device Story

EXELO2 is a CO2 laser system for dermatological ablative skin resurfacing. System components include a base unit (power supply/control interface), articulated mirror arm, and scanner handpiece. Device emits 1.6-micron wavelength monochromatic radiation; adjustable power 1-30 Watts; pulse durations 2-8 milliseconds; 250-micron spot size. Operated by clinicians in a clinical setting. Scanner handpiece allows for fractional delivery over adjustable areas (1-4 cm) with spot pitch of 0.25-3.50 mm. Aiming beam is 635 nm (<1 mW). Clinician uses system to perform skin resurfacing; output affects tissue ablation to achieve clinical resurfacing goals.

Clinical Evidence

Clinical study on 5 human subjects. Energy settings of 50mJ and 100mJ applied. Punch biopsies collected at 10 minutes, 3 days, 14 days, 21 days, and 28 days. Quantitative histology demonstrated substantial equivalence to predicate.

Technological Characteristics

CO2 laser system; 1.6-micron wavelength; 1-30W power; 250-micron spot size; 2-8ms pulse duration. Includes articulated mirror arm and scanner handpiece. Aiming beam 635nm. Fractional scanning unit for skin resurfacing.

Indications for Use

Indicated for ablative skin resurfacing in patients with Fitzpatrick skin types 1, 2, or 3.

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

• Reliant Fraxel re:pair Carbon Dioxide Laser (K080915)

Submission Summary (Full Text)

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K090639

pg 1 of 2

్లి

OCT 2 9 2009

### Section 5

### 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 04-10-08 [21 CFR 807.92(a)(1)].

#### Contact Information [21 CFR 807.92(a)(1)] A.

Quantel USA

601 Haggerty Lane

Bozeman, MT 59715

Tel: [phone]

Fax: [phone]

Contact person: Michael Johnson M.D.

#### Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] B.

Trade Name: EXELO2 Scanned CO2 Laser System for Dermatology

Device Common Name: CO2 Laser

Classification Name: Laser Instrument, Surgical Powered (per 21 CFR 878.4810)

Product Code: ONG

Panel: Dermatology and Plastic Surgery

Device Classification: Class II

- Predicate Devices [21 CFR 807.92(a)(3)] C.
The EXELO2 device uses similar technology and has equivalent physical output characteristics as the following predicate devices:

k080915 Reliant Fraxel re:pair Carbon Dioxide Laser

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pg 2 of 2

#### D. Device Description [21 CFR 807.92(a)(4)]

The EXELO2 is a CO2 laser device designed for dermatological use. It produces a coherent monochromatic radiation at the wavelength of 1.6 microns. The system is composed of a base which encloses the power supply and control interface, an articulated mirror arm, and a scanner handpiece.

#### E. Device Specifications [21 CFR 807.92(a)(6)]

The EXELO2 outputs a monochromatic laser beam of 1.6 micron wavelength with selectable pulse durations of between 2 and 8 milliseconds. The laser power is adjustable in the range of 1-30 Watts. The spot size is 250 microns. The aiming beam has a wavelength of 635 nanometers and a power of less than 1 milliWatt. The scanner covers areas adjustable between 1 and 4 centimeters and has a spot pitch of 0.25 to 3.50 millimeters.

#### F. Indications for Use [21 CFR 807.92(a)(5)]

The EXELO2 with the fractional scanning unit is indicated for ablative skin resurfacing in people with skin types 1, 2 or 3 based on Fitzpatrick skin type scale.

#### . G. Performance Data [21 CFR 807.92(b)(2)]

The EXELO2 was tested on a series of 5 human subjects. Energy settings of 50mJ and 100mJ were used and punch biopsies were taken at 10 minutes, 3 days, 14 days, 21 days, and 28 days. Quantitative histology demonstrated substantial equivalence.

#### Conclusion [21 CFR 807.92(b)(3)] H.

Technologically, the EXELO2 was found to be substantially equivalent to the currently cleared k080915 Reliant Fraxel re:pair Carbon Dioxide Laser. The indications for use are similar to these previously cleared devices. The risks and benefits for the EXELO2 are argued to be comparable to the predicate devices. We believe that there are no new questions of safety or efficacy raised by the introduction of the EXELO2.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

### OCT 2 9 2009

Quantel Derma GmbH % Quantel, USA Mr. Michael Johnson Medical Product Manager 601 Haggerty Lane Bozeman, Montana 59715

Re: K090639

Trade/Device Name: EXELO2 Scanned CO2 Laser System for Dermatology 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: ONG Dated: October 23, 2009 Received: October 27, 2009

Dear Mr. Johnson:

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 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); medical device reporting (reporting of medical

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### Page 2 -- Mr. Michael Johnson

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 McMillan

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4

pg 1 of 1

# Indications for Use

510(k) Number (if known): k090639

Device Name: EXELO2

Indications for Use:

The EXELO2 with the fractional scanning unit is indicated for ablative skin resurfacing in people with skin types 1, 2 or 3 based on Fitzpatrick skin type scale.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Af. Ogden formxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090639