(185 days)
Not Found
No
The description focuses on laser technology and its application, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the treatment of acne scars and wrinkles, which are medical conditions, and it aims to improve physical appearance and well-being.
No
The provided text describes the PicoSure™ workstation as a laser system used for tattoo and benign pigmented lesion removal, and for the treatment of acne scars and wrinkles. Its function involves delivering laser energy for therapeutic purposes, not for diagnosing medical conditions.
No
The device description clearly states it is a "high powered Alexandrite system" consisting of a "console," "articulated arm," and "footswitch," all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
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 about a person's health. This testing is done outside of the body (in vitro).
- PicoSure™ Workstation Function: The description clearly states that the PicoSure™ workstation is a laser system that delivers energy to the skin for treatments like tattoo removal, pigmented lesion removal, acne scar treatment, and wrinkle treatment. This is a direct treatment applied to the body, not a diagnostic test performed on a sample.
The information provided describes a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for 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.
Product codes
GEX
Device Description
The PicoSure™ workstation is a high powered Alexandrite system that delivers laser energy in the 755-nm wavelength. The system consists of a console that houses the power supply, control electronics and the laser. Laser energy is delivered to the skin via an articulated arm. The laser is activated using a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The study was performed using 40 subjects ages 47 – 64 whose skin types ranged from I to IV. Before and after ( 4 months post treatment) photographs were evaluated by three blinded evaluators, who were able to identify correctly the before and after images in 91% of the 38 subjects that returned for 4 month evaluation. The mean improvement score using the Fitzpatrick Wrinkle Severity Scale at four months was 1.2 Therefore the primary objectives of the study: correct identification of post treatment photograph of 80% or greater and FWSS improvement score of "1" or greater, have been met. There were no deaths, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported in this study. The events that were logged were typical reactions to laser treatments.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
2
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 |
| Westford, MA 01886 | |
| USA | |
| Phone number | 978-367-8736 |
| Fax number | 978-256-6556 |
| Establishment Registration | |
| 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 | |
| PicoSure™ workstation K133364 | |
| Apogee Elite laser K034030 | |
| 807.92(a)(4) - Device description | |
| The PicoSure™ workstation is a high powered Alexandrite system that | |
| delivers laser energy in the 755-nm wavelength. The system consists of | |
| a console that houses the power supply, control electronics and the | |
| laser. Laser energy is delivered to the skin via an articulated arm. The | |
| 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 |
| 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. |
4
| Characteristic | PicoSure™
Workstation
(current submission) | PicoSure™
Workstation
K133364 | PicoSure™
Workstation
K121346 | Elite
K034030 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------|
| Laser Type | alexandrite | alexandrite | alexandrite | alexandrite |
| Wavelength | 755nm | 755nm | 755nm | 755 nm |
| Maximum Average
Fluence | 6.37 J/cm² | 6.37 J/cm² | 6.37 J/cm² | 60 J/cm² |
| Repetition Rate | Single pulse, or 1,
2.5, 5, or 10 pulse(s)
per second (Hz) | Single pulse, or 1,
2.5, 5, or 10 pulse(s)
per second (Hz) | Single pulse, or
1,2,5, or 10 pulse(s)
per second (Hz) | 1 to 5 pulse(s) per
second (Hz) |
| Pulse Width | 450ps-900ps | 400ps-900ps | 400ps-900ps | 0.1 to 300 ms |
| Spot Sizes | Zoom 2-6 mm,
Fixed 2, 3, 4, 6, 8,
10 mm
with FOCUS lens
array 3mm, 6 mm | Zoom 2-6 mm,
Fixed 2, 3, 4, 6, 8,
10 mm
with FOCUS lens
array 3mm, 6 mm | Zoom 2-6 mm,
Fixed 2, 3, 4, 6, 8,
10 mm | Fixed 3, 5, 7, 10,
12.5 and 15 |
| 807.92(b)(2) CLINICAL TESTS SUBMITTED | | | | |
| Discussion of Clinical Study:
The study was performed using 40 subjects ages 47 – 64 whose skin types
ranged from I to IV. Before and after ( 4 months post treatment)
photographs were evaluated by three blinded evaluators, who were able to
identify correctly the before and after images in 91% of the 38 subjects that
returned for 4 month evaluation. The mean improvement score using the
Fitzpatrick Wrinkle Severity Scale at four months was 1.2 Therefore the
primary objectives of the study: correct identification of post treatment
photograph of 80% or greater and FWSS improvement score of "1" or
greater, have been met. There were no deaths, serious adverse events
(SAEs) or unanticipated adverse device effects (UADEs) reported in this
study. The events that were logged were typical reactions to laser
treatments | | | | |