ILUMINAGE DIODE LASER

K111454 · Cynosure, Inc. · OHS · Jul 5, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K111454
• Device Name: ILUMINAGE DIODE LASER
• Applicant: Cynosure, Inc.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Jul 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Iluminage laser device is indicated for use in the treatment of periorbital and perioral wrinkles.

Device Story

Diode laser system consisting of handpiece, base unit, and charger unit. Designed for treatment of periorbital and perioral wrinkles. Operates as a powered laser surgical instrument. Intended for over-the-counter use. Device delivers laser energy to target skin areas to address wrinkles.

Clinical Evidence

No clinical performance data provided.

Technological Characteristics

Diode laser system; includes handpiece, base unit, and charger. Operates under 21 CFR 878.4810. Class II device.

Indications for Use

Indicated for treatment of periorbital and perioral wrinkles in adults.

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

• Cynosure Affirm DO Diode Laser

Submission Summary (Full Text)

{0}------------------------------------------------

III 454

# 510(K) Summary

#### 5 2012 JUL

Cynosure, Inc. 5 Carlisle Road Westford, MA 01886

George Cho Sr. VP of Medical Technology and Regulatory Affairs

May 24, 2011

Iluminage Diode Laser

Medical Laser System

Instrument, Surgical, Powered, Laser 79-GEX 21 CFR 878.4810

Cynosure Affirm DO Diode Laser

Iluminage is a diode laser composed of a handpiece, base unit and a charger unit.

The Iluminage Diode Laser is indicated for use in the treatment of periorbital and perioral wrinkles.

The Iluminage Diode laser has the same indications for use, the same principle of operation, the same wavelength and the same technology as the predicate devices.

Nonclinical Performance Data: none Clinical Performance Data: none Conclusion:

Additional Information:

The Iluminage Diode laser is a safe and effective device for the intended uses.

none

Submitter:

Contact:

Date Summary Prepared: Device Trade Name: Common Name:

Classification Name:

Equivalent Device: Device Description:

Intended Use:

Comparison:

sification Name:

Equivalent Device:

Device Description:

Intended Use:

Comparison:

parison:

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

5 2012

JUL

Cynosure, Incorporated % Mr. George Cho Senior Vice President of Medical Technology and Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886

Re: K111454

Trade/Device Name: Iluminage Diode 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: OHS, GEX Dated: June 29, 2012 Received: July 02, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.

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.

{2}------------------------------------------------

### Page 2 -- Mr. George Cho

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 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known): K 111454

Device Name: Iluminage Laser

Indications For Use: The Iluminage laser device is indicated for use in the treatment of periorbital and perioral wrinkles.

Prescription Use (Part 21 CFR 801 Subpart D)

.

OR

Over-The-Counter Use X (Part 21 CFR 80) Subpart C)

(PLE.ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RPDsden for mkm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number K 111454