PICOSURE WORKSTATION

K140719 · Cynosure, Inc. · GEX · Sep 22, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140719
• Device Name: PICOSURE WORKSTATION
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure™ workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.

Device Story

PicoSure™ is a high-powered Alexandrite laser system (755-nm wavelength) used by clinicians in dermatology and plastic surgery. The system comprises a console housing power supply, control electronics, and laser source; energy is delivered to the skin via an articulated arm and activated by a footswitch. The device utilizes specific handpieces (3mm, 6mm) and a Focus Array lens to treat acne scars and wrinkles. By delivering short-pulse laser energy, the device targets skin tissue to improve appearance. Clinical outcomes are assessed by healthcare providers through visual evaluation of skin condition and wrinkle severity scales. The device benefits patients by providing a non-invasive method for tattoo removal, pigmented lesion clearance, and skin rejuvenation.

Clinical Evidence

Clinical study included 40 subjects (ages 47–64, Skin Types I–IV). Primary endpoints: correct identification of post-treatment photographs (target ≥80%) and Fitzpatrick Wrinkle Severity Scale (FWSS) improvement score (target ≥1). Results: 91% of 38 subjects correctly identified at 4-month follow-up; mean FWSS improvement score was 1.2. No deaths, serious adverse events, or unanticipated adverse device effects reported; observed events were typical laser treatment reactions.

Technological Characteristics

Alexandrite laser system; 755nm wavelength; 450ps-900ps pulse width; 6.37 J/cm² max average fluence; repetition rates 1, 2.5, 5, 10 Hz. Delivery via articulated arm with zoom (2-6mm) and fixed (2-10mm) handpieces, plus Focus Array (3mm, 6mm). Console-based; footswitch-activated. No specific material standards or software algorithm class provided.

Indications for Use

Indicated for tattoo and benign pigmented lesion removal; treatment of acne scars and wrinkles in patients with Skin Types I-IV.

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

• PicoSure™ workstation (K121346)
• PicoSure™ workstation (K133364)
• Apogee Elite laser (K034030)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be emerging from a single point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.

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

May 23, 2016

Cynosure, Incorporated Mr. Kevin J. O'Connell Senior Regulatory Affairs Manager 5 Carlisle Road Westford, Massachusetts, 01886

Re: K140719

Trade/Device Name: Picosure™ Workstation 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: August 27, 2014 Received: August 29, 2014

Dear Mr. O'Connell

This letter corrects our substantially equivalent letter of September 22, 2014.

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

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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 (OS) 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director 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) K140719

Device Name Picosure™ Workstation

Indications for Use (Describe)

The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure™ workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| 807.92(a)(1) - Submitter Information | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Cynosure, Inc. |
| Address | 5 Carlisle Road<br>Westford, MA 01886<br>USA |
| Phone number | 978-367-8736 |
| Fax number | 978-256-6556 |
| Establishment Registration<br>Number | 1222993 |
| Name of contact person | Kevin J. O'Connell |
| Date prepared | April 4, 2016 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietary name | PicoSure™ workstation |
| Common or usual name | laser |
| Classification name | Instrument, Surgical, Powered, laser |
| Classification panel | General and Plastic Surgery |
| Regulation | 21 CFR 878-4810 |
| Product Code(s) | GEX |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| | PicoSure™ workstation K121346<br>PicoSure™ workstation K133364<br>Apogee Elite laser K034030 |
| 807.92(a)(4) - Device description | |
| The PicoSure™ workstation is a high powered Alexandrite system that<br>delivers laser energy in the 755-nm wavelength. The system consists of<br>a console that houses the power supply, control electronics and the<br>laser. Laser energy is delivered to the skin via an articulated arm. The<br>laser is activated using a footswitch. | |
| 807.92(a)(5) Intended use of the device | |
| Indications for use | The PicoSure™ workstation is indicated for tattoo and benign<br>pigmented lesions removal. The PicoSure™ workstation with the 3mm<br>and 6mm hand pieces and the Focus Array are indicated for the<br>treatment of acne scars and wrinkles in Skin Types I-IV. |

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| Characteristic | PicoSure™<br>Workstation<br>(current submission) | PicoSure™<br>Workstation<br>K133364 | PicoSure™<br>Workstation<br>K121346 | Elite<br>K034030 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------|
| Laser Type | alexandrite | alexandrite | alexandrite | alexandrite |
| Wavelength | 755nm | 755nm | 755nm | 755 nm |
| Maximum Average<br>Fluence | 6.37 J/cm² | 6.37 J/cm² | 6.37 J/cm² | 60 J/cm² |
| Repetition Rate | Single pulse, or 1,<br>2.5, 5, or 10 pulse(s)<br>per second (Hz) | Single pulse, or 1,<br>2.5, 5, or 10 pulse(s)<br>per second (Hz) | Single pulse, or<br>1,2,5, or 10 pulse(s)<br>per second (Hz) | 1 to 5 pulse(s) per<br>second (Hz) |
| Pulse Width | 450ps-900ps | 400ps-900ps | 400ps-900ps | 0.1 to 300 ms |
| Spot Sizes | Zoom 2-6 mm,<br>Fixed 2, 3, 4, 6, 8,<br>10 mm<br>with FOCUS lens<br>array 3mm, 6 mm | Zoom 2-6 mm,<br>Fixed 2, 3, 4, 6, 8,<br>10 mm<br>with FOCUS lens<br>array 3mm, 6 mm | Zoom 2-6 mm,<br>Fixed 2, 3, 4, 6, 8,<br>10 mm | Fixed 3, 5, 7, 10,<br>12.5 and 15 |
| 807.92(b)(2) CLINICAL TESTS SUBMITTED | | | | |
| Discussion of Clinical Study:<br>The study was performed using 40 subjects ages 47 – 64 whose skin types<br>ranged from I to IV. Before and after ( 4 months post treatment)<br>photographs were evaluated by three blinded evaluators, who were able to<br>identify correctly the before and after images in 91% of the 38 subjects that<br>returned for 4 month evaluation. The mean improvement score using the<br>Fitzpatrick Wrinkle Severity Scale at four months was 1.2 Therefore the<br>primary objectives of the study: correct identification of post treatment<br>photograph of 80% or greater and FWSS improvement score of "1" or<br>greater, have been met. There were no deaths, serious adverse events<br>(SAEs) or unanticipated adverse device effects (UADEs) reported in this<br>study. The events that were logged were typical reactions to laser<br>treatments | | | | |