(86 days)
No
The summary describes a laser system with user-controlled parameters and feedback mechanisms, but there is no mention of AI or ML being used for image processing, treatment planning, or any other function.
Yes
The device is indicated for the treatment of various medical conditions such as the removal of tattoos, benign pigmented lesions, acne scars, and wrinkles, which are all typically treated by therapeutic devices for medical benefit.
No
The PicoWay laser system is used for treatment purposes (tattoo removal, benign pigmented lesion removal, acne scar treatment, wrinkle treatment), not for diagnosing conditions.
No
The device description explicitly states that the PicoWay Laser System is comprised of a system console, an articulated arm, and an attached handpiece, which are all hardware components.
Based on the provided information, the PicoWay laser system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- PicoWay Function: The PicoWay laser system directly interacts with the patient's skin using laser energy. It is used for therapeutic and aesthetic purposes (tattoo removal, pigmented lesion removal, acne scar treatment, wrinkle treatment).
- No Specimen Analysis: The description of the PicoWay system and its intended uses does not involve the analysis of any biological specimens taken from the patient.
Therefore, the PicoWay laser system falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic device.
N/A
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Improvement in wrinkles appearance by 2 blinded evaluators exceeded the primary endpoint criterion of 80%.
Improvement rate based on investigator assessments was 92% at the 12-week follow-up visit.
Mean elastosis score improvement was 1.44±0.83.
Investigator satisfaction rate was 88%.
Subjects' satisfaction rate was 74% at the last visit.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K143105, K140719, K133364, K121346, K162454, K160607, K153527, K150326, K142372
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K120510, K140122, K133283, K112715, K033461
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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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)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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VII. 510(K) SUMMARY
510(k) Summary PicoWay Laser System
| Submitted by: | Syneron Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ruthie Amir
Global Vice President of Clinical, Regulatory, and Education
Tel: 508-358-7400 x330
Fax: 508-358-5602 |
| Date prepared: | February 28, 2017 |
| Trade Name: | PicoWay Laser System |
| Common Name: | Dermatology Laser System |
| Classification: | Class II
Laser surgical instrument for use in general and plastic surgery and in
dermatology (21 CFR 878.4810)
Product Code GEX |
Predicate and Reference Devices:
| Predicate Devices: | Cynosure PicoSure™ workstation (K143105, K140719, K133364, K121346)
(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
6
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.