AURA ISURGICAL LASER SYSTEM & ACCESSORIES

K024206 · Laserscope · GEX · Nov 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024206
• Device Name: AURA ISURGICAL LASER SYSTEM & ACCESSORIES
• Applicant: Laserscope
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Laserscope Aura i Laser System & Accessories is indicated to treat moderate inflamatory acne vulgaris.

Device Story

Aura i Surgical Laser System is a powered laser instrument used for treating moderate inflammatory acne vulgaris. The system consists of a laser console, fiber port for delivery devices, control/display panels, operating software, footswitch/handswitch controls, and a cooling sub-system. Operated by clinicians in a clinical setting, the device delivers laser energy to the target area. The system provides therapeutic intervention for acne management. Clinical benefit is derived from the laser treatment of inflammatory lesions.

Technological Characteristics

Laser surgical instrument; powered console with fiber delivery port, control/display panels, and cooling sub-system. Conforms to 21 CFR 1040.10 and 1040.11 performance standards for medical laser systems.

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris.

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

• Laserscope Aura™ Laser System and Accessories
• Clearlight Phototherapy System Model C420 (ClearLight™, Lumenis)

Reference Devices

• Laserscope Lyra Laser System and Accessories
• Modified Coherent VersaPulse Select Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers

Submission Summary (Full Text)

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Ko24206 1/2

NOV. 1 7 2003

## 510(k) Summary Statement For the AURA™ i Surgical Laser System & Accessories for the Treatment of Moderate Acne vulgaris

## General Information

- A. Trade Name Aura™ i Surgical Laser System & Accessories
- B. Common Name Laser Instrument, Surgical, Powered
- C. Establishment Registration Number

2937094

- D. Manufacturer's Identification
Laserscope 3070 Orchard Drive San Jose, CA 95134-2011 [phone] [phone] FAX

Official Correspondent Paul Hardiman Manager, Regulatory Affairs/Clinical Affairs

- E. Device Classification
The Aura i Surgical Laser System has been specifically classified as a Class II medical device by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels.

- F. Performance Standards
The Aura i Surgical Laser System conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.

- G. Predicate Devices:
- Laserscope Aura™ Laser System and Accessories ●
- Clearlight Phototherapy System Model C420 (ClearLight™, Lumenis) .

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H. Product Description:

The Laserscope Aura i Surgical Laser System & Accessories are comprised of the following main components:

- A Laser Console ●
- A Fiber Port (for Delivery Devices) 0
- Control and Display Panels .
- Operating Software ●
- Footswitch and Handswitch Delivery Controls .
- . Accessories
- A Cooling Sub-system ●
- 1. Indications For Use:

The Laserscope Aura i Laser System is indicated to treat moderate inflammatory acne vulgaris.

- . ل. Rationale for Substantial Equivalence
The Laserscope Aura i Laser System & Accessories and the ClearLight Phototherapy System, Model CL 420 share the same indications for use, similar design features, functional features, and therefore are substantially equivalent to: Laserscope Lyra Laser System and Accessories; and, the Modified Coherent VersaPulse Select Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices and Accessories. Details are provided in the Substantial Equivalence Section of this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

NOV 17 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul H. Hardiman Manager, Regulatory Affairs Laserscope 3070 Orchard Drive San Jose, California 95134-2011

Re: K024206

Trade/Device Name: Aura™i Surgical Laser System and Accessories 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: September 16, 2003 Received: September 17, 2003

Dear Mr. Hardiman:

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. Paul H. Hardiman

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

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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## INDICATIONS FOR USE STATEMENT

Page 1

510(k) Number:

027206

Device Name:

AURA i SURGICAL LASER SYSTEM & ACCESSORIES

INTENDED USE:

The Laserscope Aura i Laser System & Accessories is indicated to treat moderate inflamatory acne vulgaris.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: or Over The-Counter-Use (per 21 CFR 801.109)

Miriam C. Provost

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

510(k) Number K024206

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