PicoWay Laser System
Device Facts
| Record ID | K170597 |
|---|---|
| Device Name | PicoWay Laser System |
| Applicant | Syneron Candela Corporation |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | May 25, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The PicoWay laser system is indicated for the following at the specified wavelength: 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The Resolve handpieces are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Device Story
Solid-state laser system delivers 532nm, 785nm, or 1064nm wavelengths via articulated arm and handpiece; pulse durations 240–750 ps; repetition rates up to 10 Hz. Used in clinical settings by physicians to treat tattoos, pigmented lesions, acne scars, and wrinkles via selective photothermolysis. Console allows user to select energy density, repetition rate, and monitor pulse counts/spot sizes. Internal meter verifies arm transmission. Clinical benefit includes improved appearance of wrinkles and removal of pigment/tattoos. Well-tolerated with transient side effects like erythema/edema.
Clinical Evidence
Prospective, self-controlled, multicenter study (n=72 treated) evaluated Resolve handpieces for wrinkle improvement. Primary endpoint: 82% of treated areas showed improvement (correct photo identification and elastosis score improvement) after 3-6 sessions, exceeding 80% threshold. 12-week follow-up showed 92% improvement rate; mean elastosis score improvement 1.44±0.83. Investigator satisfaction 88%, subject satisfaction 74%. No serious adverse events; transient erythema, edema, and discomfort reported.
Technological Characteristics
Solid-state laser; wavelengths 532/785/1064 nm; pulse width 240-750 ps; repetition rate up to 10 Hz. Articulated arm delivery with adjustable spot sizes up to 10 mm. Console-based user interface. Electrical safety per IEC 60601-1, EMC per IEC 60601-1-2. Biocompatibility per ISO 10993.
Indications for Use
Indicated for tattoo removal (Fitzpatrick I-VI, specific colors), benign pigmented lesion removal (Fitzpatrick I-IV), acne scar treatment (Fitzpatrick II-V), and wrinkle treatment (Fitzpatrick 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
- Cynosure PicoSure™ workstation (K143105, K140719, K133364, K121346)
- Syneron-Candela's PicoWay Laser System (K162454, K160607, K153527, K150326, K142372)
Reference Devices
- Syneron Medical Ltd.'s Transcend System (K120510)
- Candela Corporation's GentleMAX Pro laser system (K140122, K133283, K112715)
- Candela Corporation's VBeam Laser System (K033461)
Submission Summary (Full Text)
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
May 25, 2017
Syneron Candela Corporation % Janice Hogan Regulatory Counsel Hogan Lovells Us Llp 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K170597
Trade/Device Name: Picoway Laser System 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: February 28, 2017 Received: February 28, 2017
Dear Janice Hogan:
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 Actinclude 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
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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 devicerelated 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 (800) 638-2041 or (301) 796-7100 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" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
# Jennifer R. Stevenson -S
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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
K170597
Device Name
PicoWay Laser System Indications for Use (Describe)
The PicoWay laser system is indicated for the following at the specified wavelength:
532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-V.
The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
The Resolve handpieces are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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#### VII. 510(K) SUMMARY
# 510(k) Summary PicoWay Laser System
| Submitted by: | Syneron Candela Corporation<br>530 Boston Post Road<br>Wayland, MA 01778-1886 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ruthie Amir<br>Global Vice President of Clinical, Regulatory, and Education<br>Tel: 508-358-7400 x330<br>Fax: 508-358-5602 |
| Date prepared: | February 28, 2017 |
| Trade Name: | PicoWay Laser System |
| Common Name: | Dermatology Laser System |
| Classification: | Class II<br>Laser surgical instrument for use in general and plastic surgery and in<br>dermatology (21 CFR 878.4810)<br>Product Code GEX |
#### Predicate and Reference Devices:
| Predicate Devices: | Cynosure PicoSure™ workstation (K143105, K140719, K133364, K121346)<br>(Primary Predicate); Syneron-Candela's PicoWay Laser System (K162454, K160607, K153527, K150326, K142372) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference devices: | Syneron Medical Ltd.'s Transcend System (K120510), Candela Corporation's GentleMAX Pro laser system (K140122, K133283, K112715), Candela Corporation's VBeam Laser System (K033461) |
#### Intended Use / Indications for Use:
The PicoWay laser system is indicated for the following at the specified wavelength:
532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
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The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
The Resolve handpieces are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
# Description:
The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240–750 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a handpiece. The light-weight and ergonomic handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System (up to 10 mm). The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
# Technological Characteristics:
The PicoWay Laser System has the same intended use and similar indications for use, technological characteristics and operating principles as the Cynosure PicoSure™ workstation (K143105, K140719, K133364, K121346) and the PicoWay Laser System (K162454, K160607, K153527, K150326, K142372). The PicoWay design and components are identical to the previously cleared PicoWay devices and are very similar to those of the PicoSure device. The primary purpose of this submission is to expand the indications for use of the PicoWay to include the treatment of wrinkles, which is included in the indications for use of the PicoSure predicate. For each of these device systems, the treatment handpiece is attached to an articulating arm that is connected to the main system console. For each system, the user interface is located at the front/top of the console. For the PicoWay and predicate devices, the laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system with a handpiece attached to the end. Treatment parameters can be adjusted according to device specifications. Each system thus consists of the articulating arm (and attached handpiece), as well as an electrically powered system console that houses the software, user interface, and produces the laser energy. The PicoWay provides the same or similar key design aspects, including the same or similar spot sizes, laser wavelengths, pulse width, and laser types, as its predicate devices. The frequency (repetition rate) of the PicoWay System is the same as or within the frequency range of the predicates. Further, each of the devices presents a range of spot sizes to allow the user to choose the most appropriate spot size for each patient. The wavelengths available with the PicoWay are the same as or similar to those presented by the predicates. Therefore, the minor differences do not raise any new types of safety or effectiveness questions because the PicoWay parameters are the same as or within the range of the predicates.
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### Performance Data:
Electrical Safety and Electromagnetic Compatibility: Electrical safety and electromagnetic compatibility (EMC) testing for the PicoWay Laser System was conducted by an independent test laboratory in accordance with IEC 60601-1, Medical equipment, Part 1: General requirements for basic safety and essential performance and with IEC 60601-1-2, Collateral Standard: Electromagnetic Compatibility - Requirements and Tests, 3rd ed. The PicoWay System was determined to be in conformance with applicable IEC standards (IEC 62366, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1).
Biocompatibility: The biocompatibility of the PicoWay device has also been established per ISO 10993 guidelines based on the biocompatibility of the PicoWay predicate.
Software: Software for the PicoWay device is identical to that for the PicoWay predicate. Software verification and validation testing results were found acceptable for software release.
Bench Testing: The PicoWay device is technologically identical to the PicoWay predicate (K162454, K160607). As previously cleared in the predicate PicoWay System, bench testing verified that energy measurements met specifications. Therefore, no further bench testing is required to evaluate device performance.
Clinical Data: Several prospective studies have been conducted to evaluate the PicoWay System, and results consistently demonstrate the favorable safety and performance profiles of the PicoWay System for its indicated uses. In support of the proposed additional indication for the treatment of wrinkles, a single arm, prospective, self-controlled, multicenter study was conducted to evaluate the PicoWay device using the Resolve handpieces (532nm or 1064nm wavelengths) for improvement in the appearance of wrinkles. A total of 74 subjects were enrolled and 72 subjects were treated at 4 sites in the United States. Following 3-6 treatment sessions, 82% of treated areas showed improvement in wrinkles appearance, as assessed (by the correct identification of the post treatment photograph and assessment of at least one Elastosis Score unit) by 2 blinded evaluators, exceeding the primary endpoint criterion of 80%. Additional statistical analyses further illustrate the favorable efficacy results achieved with the PicoWay. In addition, based on investigator assessments, improvement rate was 92% at the 12 week follow-up visit and the mean elastosis score improvement was 1.44±0.83. Investigator satisfaction rate was 88% and subjects' satisfaction rate was 74% at the last visit.
Treatment with the PicoWay System also demonstrated a very positive safety profile. There were no adverse events reported during the study course. However, out of an abundance of caution, 2 subjects who reported severe pain on the treatment day were counted as adverse events, both of which improved on the next day and resolved completely without intervention. Anticipated treatment responses such as erythema, edema, tingling, crusting and acne breakout following treatment were observed, and these effects resolved within days after treatment without medical intervention. Most of the subjects reported low levels of pain during treatment and discomfort in the week following treatment, further confirming that the device was well tolerated.
Based on the clinical data, the clinical study results did not present any different types of safety or effectiveness questions as compared to the predicate device. The clinical study achieved study success and demonstrated the safety and performance of the PicoWay System's Resolve
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handpieces in achieving improvement in the appearance of wrinkles. All performance testing demonstrated that the PicoWay Laser System performs according to specifications and functions as intended.
# Summary of Substantial Equivalence:
The PicoWay and the predicate devices have the same intended use with similar indications for use. The PicoWay Laser System presents the same or similar technological characteristics as its predicate devices, including the laser type, wavelengths, device design, pulse width, frequency, spot sizes and system components. Any minor differences do not present any new types of safety or effectiveness questions since the PicoWay parameters are similar to or within the range of the predicates. Further, PicoWay performance has been demonstrated in clinical and non-clinical investigations, and results confirm the safety and performance of the device. The PicoWay device and its predicates all operate with the same mechanism of action based on selective photothermolysis of pigment particles using laser energy. Therefore, the PicoWay has the same intended use and similar indications for use, technological characteristics, and principles of operation as the predicate devices. The PicoWay is substantially equivalent to the predicate devices.
# Conclusions:
Testing of the PicoWay device demonstrated that the device performs as intended. Results in the clinical studies further demonstrate use of the device for treatment of wrinkles, in support of substantial equivalence. The PicoWay System is substantially equivalent to the predicate devices.
