(207 days)
No
The description focuses on the laser technology and its mechanism of action for tattoo and pigment removal. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the removal of tattoos and benign pigmented lesions, which are conditions that disrupt the normal function or appearance of the skin, therefore serving a therapeutic purpose to restore or improve the skin's state.
No
The device description and intended use state that the PicoSure™ workstation is for tattoo and benign pigmented lesions removal, which is a treatment, not a diagnostic, function.
No
The device description clearly states it is a "high-powered, laser system," indicating it is a hardware device that delivers energy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tattoo and benign pigmented lesions removal." This is a therapeutic or cosmetic procedure performed directly on the patient's skin.
- Device Description: The device is a "high-powered, laser system" that delivers energy to the skin to break down pigments. This is a physical intervention, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information about a person's health.
The PicoSure™ workstation is a therapeutic laser device used for treating conditions on the skin, not for diagnosing conditions by testing samples.
N/A
Intended Use / Indications for Use
The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal.
Product codes
GEX
Device Description
The PicoSure™ workstation is a high-powered, laser system that delivers energy in the 755-nm wavelength. Same as its predicates, the PicoSure™ workstation is intended for tattoos and benign pigmented lesions removal. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance (bench and animal) testing summaries are included in this submission. Bench testing included:
- Design verification which includes software and hardware verification
- Design validation which includes software and hardware validation .
- Production verification which includes in-process inspection and test
Animal data has been used to establish the device safety. A study examined the effect of the PicoSure™ workstation in an animal model (porcine study).
Three clinical studies (two controlled and one uncontrolled) were presented in the submission to confirm safety and effectiveness of the device in the tattoo removal. Number of treatments varied in the studies from 4 to 10 sessions. The device effectiveness in removal tattoos was assessed by the evaluation before-and-after photos and calculation the % of tattoo clearance at the end of study for each treatment area. Subject and physician satisfaction with the treatment results was also surveyed and analyzed.
The device safety was evaluated by the incidence, timing, severity of treatment-emergent adverse events were categorized and summarized.
The device was found to be safe and effective, with high level of overall tattoo clearance and "extreme," physician satisfaction (physician evaluation) and, additionally, demonstrated more significant % of highest clearance score than control device in controlled studies.
Treatment-emergent adverse events were recorded and evaluated in all studies. All treatment arms had a comparable safety profile. None of the events were classified as adverse device reaction. No serious or unexpected adverse events were reported. The majority of reported adverse events across the studies were of mild severity; no severe adverse events were reported in any group. The most common reactions were pain and blistering.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 image of three human profiles facing right, stacked slightly offset from each other. Above the profiles is a design element resembling a wing or feather. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2016
Cynosure, Incorporated Ms. Irina Kulinets Vice President of Regulatory Affairs and Quality Systems 5 Carlisle Road, Westford, Massachusetts, 01886
Re: K121346 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: November 8, 2012 Received: November 9, 2012
Dear Ms. Kulinets:
This letter corrects our substantially equivalent letter of November 27, 2012.
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 vour 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
1
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-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" (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
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Indications for Use
510(k) Number (if known) K121346
Device Name Picosure™ workstation
Indications for Use (Describe)
The PicoSure™ workstation 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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510(k) Summary
| 510(K) Owner: | CYNOSURE, INC.
5 Carlisle Road
Westford, MA 01886
Telephone: 978-256-4200
Fax: 978 256 6556 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact: | Irina Kulinets
VP of Regulatory Affairs and Quality Systems
CYNOSURE, INC.
5 Carlisle Road
Westford, MA 01886 |
| Submitter: | Connie Hoy
SVP of Regulatory Affairs and Quality Systems
CYNOSURE, INC.
5 Carlisle Road
Westford, MA 01886 |
| Manufacturer: | CYNOSURE, INC.
5 Carlisle Road
Westford, MA 01886 |
| Date Prepared: | March 29, 2016 |
| Trade name: | PicoSureTM workstation |
| Common name: | Powered Laser Surgical Instrument (Laser
for Surgery and Dermatology) |
| Classification name: | 21 CFR 878.4810 |
| Product Code(s): | GEX (Laser Surgical Instrument for Use in General and
Plastic Surgery and in Dermatology) |
| Classification: | Class II |
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Review Panel:
General & Plastic Surgery
Predicate Devices (Claiming Substantial Equivalence):
K992814 Cynosure Accolade/Accolade II Laser K103118 HOYA ConBio RevLite
Summary Description of the Device:
The PicoSure™ workstation is a high-powered, laser system that delivers energy in the 755-nm wavelength. Same as its predicates, the PicoSure™ workstation is intended for tattoos and benign pigmented lesions removal. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed.
Intended Use / Indications for Use:
The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal.
Technological Characteristics:
The PicoSure™ workstation contains equivalent basic technology, components and patient-contact materials as the FDA cleared Cynosure Accolade/Accolade II laser (K992814 and K072868). The fundamental scientific technology of the PicoSure™ workstation is substantially equivalent to the FDA cleared Cynosure Accolade/Accolade II laser (K992814 and K072868).
Performance Standards:
This device conforms to the Laser Performance Standard (21 CFR 1040). No additional performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
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Performance Data: Non-clinical testing
Performance (bench and animal) testing summaries are included in this submission. Bench testing included:
- . Design verification which includes software and hardware verification
- Design validation which includes software and hardware validation .
- . Production verification which includes in-process inspection and test
Animal data has been used to establish the device safety. A study examined the effect of the PicoSure™ workstation in an animal model (porcine study).
Performance Data: Clinical testing
Three clinical studies (two controlled and one uncontrolled) were presented in the submission to confirm safety and effectiveness of the device in the tattoo removal. Number of treatments varied in the studies from 4 to 10 sessions. The device effectiveness in removal tattoos was assessed by the evaluation before-and-after photos and calculation the % of tattoo clearance at the end of study for each treatment area. Subject and physician satisfaction with the treatment results was also surveyed and analyzed.
The device safety was evaluated by the incidence, timing, severity of treatment-emergent adverse events were categorized and summarized.
The device was found to be safe and effective, with high level of overall tattoo clearance and "extreme," physician satisfaction (physician evaluation) and, additionally, demonstrated more significant % of highest clearance score than control device in controlled studies.
Treatment-emergent adverse events were recorded and evaluated in all studies. All treatment arms had a comparable safety profile. None of the events were classified as adverse device reaction. No serious or unexpected adverse events were reported. The majority of reported adverse events across the studies were of mild severity; no severe adverse events were reported in any group. The most common reactions were pain and blistering.
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Substantial Equivalence:
The Cynosure PicoSure™ workstation is as safe and effective as its predicate devices currently cleared for the same indications. The Cynosure PicoSure™ workstation is substantially equivalent to the predicate device(s) as shown in the table below and does not does not raise any additional questions of safety and effectiveness. Substantial Equivalence Table is provided below.
| Proposed Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| 510(k) # | K992814 | K103118 | |
| Company | CYNOSURE, INC. | CYNOSURE, INC. | HOYA ConBio |
| Name | Cynosure PicoSure™ | ||
| workstation | Cynosure | ||
| Accolade | RevLite | ||
| Laser Type | Flashlamp excited Q- | ||
| switched alexandrite | Flashlamp excited Q- | ||
| switched alexandrite | Flashlamp excited Q- | ||
| switched alexandrite | |||
| Nominal Wavelength | 755nm | 755nm | 532 nm, 585 nm 650 nm, |
| & 1064 nm | |||
| Energy per pulse | 0.2 J/cm2 | 0.57 J/cm2 | 0.85 J/cm2 |
| Maximum Average | |||
| Fluence | 6.37 J/cm2 | 7.5 J/cm2 | 12 J/ cm² (1064nm) |
| 5 J/ cm² (532nm) | |||
| 10 J/ cm² (585nm) | |||
| 6 J/ cm² | |||
| (650 nm) | |||
| 1.2 J/ cm² (532Lite) | |||
| Rate | 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) | Single & double pulse, 1, | ||
| 2, 5, & 10 Hz pulses per | |||
| second | |||
| Pulse Width | 450ps - 900ps | 45-75 ns | 5-20 ns |
| Spot Sizes | Zoom 2-6 mm, | ||
| Fixed 2, 3, 4, 6, 8, 10 | |||
| mm | Fixed | ||
| 2.4, 3, 4 mm | Fixed 2 - 8 mm (varies by | ||
| wavelength) |
Device Comparison Table - Substantial Equivalence
Conclusion:
PicoSure™ workstation is as safe and efficient as its predicate devices.
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