ILUMINAGE SKIN SMOOTHING LASER

K133473 · Cynosure, Inc. · OHS · Jan 15, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133473
• Device Name: ILUMINAGE SKIN SMOOTHING LASER
• Applicant: Cynosure, Inc.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Jan 15, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Iluminage Skin Smoothing Laser is a battery-powered, home-use (OTC) diode laser system. Device emits continuous wave 1440nm laser energy to fixed skin areas; energy triggers natural collagen generation to tighten skin and reduce wrinkles. System includes handpiece, base unit, charging adapter, and USB data cable. User operates device at home. Handpiece contains laser diode, power source, and control electronics with embedded software. Modifications include updated arming sequence (one long 3-5 second press), flexible charging methods (base unit or direct USB/power cord), and updated indicator colors for skin contact and energy delivery. Device includes data acquisition capabilities. Healthcare providers do not operate the device; users follow instructions for use to perform treatments. Output is laser energy delivery; clinical benefit is wrinkle reduction.

Clinical Evidence

Bench testing only. Software verification testing confirmed that modifications (arming sequence, charging, indicators, data acquisition) were correctly implemented and the device meets product system requirements.

Technological Characteristics

Diode laser; 1440nm wavelength; 3-4 J/cm² fluence; 7mm spot size; 1 Hz repetition rate. Battery-powered handpiece with base unit or direct USB/power cord charging. Embedded software for control electronics and data acquisition. User interface includes skin contact and energy delivery indicators.

Indications for Use

Indicated for treatment of periorbital and perioral wrinkles in adults for over-the-counter home use.

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 Iluminage Diode Laser (K111454)

Submission Summary (Full Text)

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JAN 15 2014

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## Section 6: 510(k) Summary

This 510(k) Summary information is submitted in accordance with the requirements of 21 C.F.R. 807.92.

| <b>807.92(a)(1) - Submitter Information</b> | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Name | Cynosure Inc. |
| Address | 5 Carlisle Road<br>Westford, MA 01886 |
| Phone number | 978-367-8736 |
| Fax number | 978-256-6556 |
| Establishment<br>Registration Number | 1222993 |
| Name of contact person | Kevin J. O'Connell |
| Date prepared | January 15, 2014 |
| <b>807.92(a)(2) - Name of device</b> | |
| Trade or proprietary name | Iluminage Skin Smoothing Laser |
| Common or usual name | Medical Laser System |
| Classification name | Light Based Over the Counter Wrinkle Reduction |
| Classification panel | General and Plastic Surgery |
| Regulation | 878.4810 |
| Product Code(s) | OHS |
| <b>807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed</b> | |
| Cynosure Iluminage Diode Laser, K111454 | |
| <b>807.92(a)(4) - Device description</b> | |
| The Iluminage Skin Smoothing Laser is a battery powered, home use (OTC) diode laser. The device emits continuous wave diode laser energy for a specified period of time to a fixed area of skin. This energy triggers the body's natural response to generate new collagen, which helps tighten the skin which reduces wrinkles.<br><br>The device is composed of a handpiece for delivery of laser energy, base unit for charging and storage when not in use, an A.C. charging adapter, Instructions for Use, USB data cable and carrying pouch. The handpiece contains a 1440nm laser diode light source, internal energy power source and control electronics with embedded software. The device has been modified to add user convenience features. | |

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| Indications for use | | The Iluminage Skin Smoothing Laser is indicated for use in the treatment of<br>periorbital and perioral wrinkles. | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| | | The modifications to the device have not changed the indications for use for<br>the device. | |
| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate | | | |
| Characteristic | | Iluminage Diode Laser | Iluminage Skin Smoothing Laser |
| Device Type | | Diode Laser | Diode Laser |
| Wavelenght<br>(nm) | | 1440 | 1440 |
| Fluence (J/cm²) | | 3-4 | 3-4 |
| Spot Size (mm) | | 7 | 7 |
| Rep. Rate | | 1 | 1 |
| Data acquisition | | No | Yes |
| Handpiece<br>charging method | | In base unit | In base unit or<br>direct connection to USB cable or power<br>cord |
| Skin Contact<br>Indicator Color | | Blue | White |
| Energy<br>Delivered<br>Indicator Color | | White | Blue |
| Arming<br>sequence | | Short, short, long button presses | One long press of 3-5 seconds |
| 807.92(b)(1-2) Nonclinical tests submitted | | | |
| Test | | Result | |
| Iluminage Software Verification | | The testing confirmed that modifications made to the device<br>were correctly implemented. This included operating the device<br>to insure: when the revised arming sequence is followed the laser<br>would function; treatment levels can be changed; indicators such<br>as skin contact, battery status, treatment count and high<br>temperature limits would function; and that data acquisition<br>could be performed. | |
| 807.92(b)(3) Conclusions drawn from non-clinical data | | | |
| Testing confirmed that the performance of the Iluminage Skin Smoothing Laser meets the product system<br>requirements, which is based on the predicate device. Therefore, the modification resulted in a device that<br>performs the same as the predicate device. | | | |

·

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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 eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

## Public Health Service

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

Cynosure Incorporated Mr. Kevin J. O'Connell Manager Regulatory Affairs 5 Carlise Road Westford, Massachusetts 018886

January 15, 2014

Re: K133473

Trade/Device Name: Cynosure Iluminage Skin Smoothing Laser 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: OHS Dated: December 16, 2013 Received: December 17, 2013

Dear Mr. O'Connell:

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.

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

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Page 2 - Mr. Kevin J. O'Connell

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K133473

Device Name: Cynosure Iluminage Skin Smoothing Laser

Indications For use: The Iluminage Skin Smoothing Laser is indicated for use in the treatment of periorbital and perioral wrinkles.

PRESCRIPTION USE _ (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden S
2014.01.14 09:47:55 -05'00'

(Division Sign-Off) for BSA

Division of Surgical Devices

510(k) Number_K133473