(85 days)
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No
The document describes a laser system for tattoo and lesion removal and wrinkle treatment. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on clinical efficacy and safety, not on the performance of any AI/ML algorithm.
Yes
The device is used for the treatment of acne scars and wrinkles, and for the removal of tattoos and benign pigmented lesions, which are all therapeutic applications.
No
The device is indicated for tattoo and benign pigmented lesion removal, and for the treatment of acne scars and wrinkles. These are therapeutic applications, not diagnostic ones.
No
The device description clearly states it is a "high-powered, Alexandrite system that delivers laser energy" and mentions handpieces and an articulated arm, indicating it is a hardware-based laser system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "tattoo and benign pigmented lesions removal," "treatment of acne scars and wrinkles," and "tattoo removal." These are all therapeutic or cosmetic procedures performed directly on the patient's body.
- Device Description: The description details a laser system that delivers energy to the patient's skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a therapeutic laser system used for direct treatment.
N/A
Intended Use / Indications for Use
755 nm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV.
532 nm:
The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I - III.
1064 nm:
The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PicoSure™ workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755 nm handpiece, optional 532 nm Laser Delivery System and/or 1064 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755 nm laser energy into a 532 nm wavelength or a 1064 nm wavelength and are available in multiple spot sizes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The study was performed using 66 subjects with a total of 79 tattoos. Subjects received up to 12 treatments, one every 6 weeks (+/- 2 weeks). Subjects were divided into two groups and treated exclusively with PicoSure, or their tattoo was split into two treatments areas, and treated with PicoSure and the predicate device. Three blinded reviewers performed an evaluation of photographs using a 6 points categorical efficacy scoring scale as well as rating the cattoos. Mean scores for all three evaluators were calculated per subject to determine overall mean scores. The results of the blinded evaluation were subjects treated with PicoSure were rated 4.1/6 overall mean score, showing the PicoSure to be as effective as the predicate device RevLite, which had an average score of 3.7/6. There were no deaths, serious adverse events (SAE) or unanticipated adverse device effects (UADEs) reported in this study. The primary objectives of the study; to assess overall treatment efficacy through blinded photographic evaluation using a 6 point scale to grade improvement, assess safety of the PicoSure laser through the recording of side effects during the course of the study, and compare efficacy of the PicoSure laser to the predicate device in a subset of patients, have been met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
PicoSure Workstation K143105, RevLite Q-Switched Nd:YAG Laser System K133254
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.
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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).
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§ 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.
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered horizontally and appears to be part of a document header or title. The font is a serif typeface, giving it a formal and official appearance.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2016
Cynosure, Inc Ms. Amy Tannenbaum Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886
Re: K160480
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: February 19, 2016 Received: February 22, 2016
Dear Ms. Tannenbaum:
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
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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 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) K160480
Device Name
PicoSure Workstation with 1064 nm Laser Delivery System
Indications for Use (Describe)
755 nm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV.
532 nm:
The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I - III.
1064 nm:
The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
PicoSure™ Workstation 510(k) Summary KPending
| 807.92(a)(1) Submitter Information | |
|---|---|
| Applicant | Cynosure, Inc |
| Address | 5 Carlisle Road |
| Westford, MA 01886 | |
| Phone Number | (781) 993-2454 |
| Fax Number | (978) 256-6556 |
| Establishment Registration Number | 1222993 |
| Contact Person | Amy Tannenbaum |
| Preparation Date | February 19, 2016 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | PicoSure Workstation with 532 and 1064 nm Laser Delivery System |
| Common or Usual Name | Medical Laser System |
| Classification Name | Powered Laser Surgical Instrument |
| Classification Panel | General & Plastic Surgery |
| Regulation | 878.4810 |
| Product Code(s) | GEX |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | PicoSure Workstation K143105 |
| RevLite Q-Switched Nd:YAG Laser System K133254 | |
| 807.92(a)(4) Device Description | The PicoSure™ workstation is a high-powered, Alexandrite |
| system that delivers laser energy in the 755-nm nominal | |
| wavelength. The system offers fast and efficient treatment | |
| through a variety of spot sizes, fluences and repetition rates. | |
| Laser activation is by footswitch. In addition to the 755 nm | |
| handpiece, optional 532 nm Laser Delivery System and/or | |
| 1064 nm Laser Delivery System can replace the 755 nm | |
| handpiece at the distal end of the articulated arm. These | |
| Delivery Systems convert the 755 nm laser energy into a | |
| 532 nm wavelength or a 1064 nm wavelength and are | |
| available in multiple spot sizes. | |
| 807.92(a)(5) Intended Use of the Device | |
| 755 nm: | |
| The PicoSure workstation is indicated for tattoo and benign | |
| pigmented lesions removal. The PicoSure workstation with the | |
| 3mm and 6mm handpieces and the Focus Array are indicated for | |
| the treatment of acne scars and wrinkles in Skin Types I-IV. | |
| 532 nm: | |
| The PicoSure 532 nm Laser Delivery System is indicated for | |
| tattoo removal in Skin Types I - III. | |
| 1064 nm: | |
| The PicoSure 1064 nm Laser Delivery System is indicated for |
4
PicoSure™ Workstation 510(k) Summary KPending
The modifications to the device have not changed the indications for use for the 755 nm or 532 nm wavelength.
5
PicoSure™ Workstation 510(k) Summary KPending
| 807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to the Predicate | ||||||
|---|---|---|---|---|---|---|
| PicoSure™ Workstation (KPending) | PicoSure Workstation (K143105) | RevLite (K133254) | ||||
| Laser Type | Nd:YVO4 | Frequency | ||||
| doubled | ||||||
| Nd:YVO4 | Alexandrite | Frequency | ||||
| doubled 1064 nm | ||||||
| solid state laser | Alexandrite | Nd:YAG | ||||
| Wavelength | 1064 nm | 532 nm | 755 nm | 532 nm | 755 nm | 1064 nm/532 nm |
| Maximum | ||||||
| Average Fluence | 3.6 J/cm² | 1.5 J/cm² | 6.37 J/cm² | 1.5 J/cm² | 6.37 J/cm² | 12 J/cm² @ 1064 nm |
| 5 J/cm² @ 532 nm | ||||||
| Repetition Rate | 1, 2.5, 5, 10 Hz | 1, 2.5, 5, 10 Hz | Single, 1, 2.5, 5, 10 Hz | 1, 2.5, 5, 10 Hz | Single shot, | |
| or 1, 2.5, 5, | ||||||
| 10 Hz | Single shot, 1, 2, 5, 10 Hz | |||||
| Pulse Duration | 450 - 900 ps | 450 - 900 ps | 450 - 900 ps | ≤ 900 ps | ≤ 20 ns | |
| Spot Sizes (mm) | Fixed 1.4 – 4.0 mm | Fixed 1.5 – 3.5 mm | Zoom 2-6 mm, | |||
| Fixed 6, 8, 10 mm | Fixed 1.5 – 3.5 mm | Zoom 2-6 mm, | ||||
| Fixed 2, 3, 4, 6, | ||||||
| 8, 10 mm | 2-8.5 mm, 0.1 mm | |||||
| increments | ||||||
| 807.92(b)(1) Non-clinical tests submitted |
Software verification and validation testing to support the 1064 nm Laser Delivery System was successfully completed.
807.92(b)(2) Clinical tests submitted
The study was performed using 66 subjects with a total of 79 tattoos. Subjects received up to 12 treatments, one every 6 weeks (+/- 2 weeks). Subjects were divided into two groups and treated exclusively with PicoSure, or their tattoo was split into two treatments areas, and treated with PicoSure and the predicate device. Three blinded reviewers performed an evaluation of photographs using a 6 points categorical efficacy scoring scale as well as rating the cattoos. Mean scores for all three evaluators were calculated per subject to determine overall mean scores. The results of the blinded evaluation were subjects treated with PicoSure were rated 4.1/6 overall mean score, showing the PicoSure to be as effective as the predicate device RevLite, which had an average score of 3.7/6. There were no deaths, serious adverse events (SAE) or unanticipated adverse device effects (UADEs) reported in this study. The primary objectives of the study; to assess overall treatment efficacy through blinded photographic evaluation using a 6 point scale to grade improvement, assess safety of the PicoSure laser through the recording of side effects during the course of the study, and compare efficacy of the PicoSure laser to the predicate device in a subset of patients, have been met.
807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted
Testing confirmed that the PicoSure workstation with the 532 and 1064 nm Laser Delivery System is safe and effective in the removal of tattoos.