(263 days)
(K)121346, (K)103118
Not Found
No
The device description and performance studies focus on the laser technology and clinical outcomes, with no mention of AI or ML components.
Yes.
The device is indicated for the treatment of acne scars, which is a therapeutic purpose.
No
The device is indicated for treatment (tattoo and pigmented lesion removal, and acne scar treatment) rather than diagnosis.
No
The device description clearly states it is a "high-powered, Q-switched Alexandrite system" consisting of a console, power supply, control electronics, laser, 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 Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- PicoSure™ Workstation Function: The PicoSure™ workstation is a laser system that delivers energy to the skin for therapeutic purposes (tattoo removal, benign pigmented lesion removal, and acne scar treatment). It directly interacts with the patient's body and does not analyze samples taken from the body.
- Intended Use: The stated intended use is for the removal of tattoos and lesions, and the treatment of acne scars. These are all direct treatments applied to the patient's skin.
- Device Description: The description details a laser system with a console, power supply, control electronics, laser, articulated arm, and footswitch. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic assays, which are hallmarks of IVD devices.
Therefore, based on the provided information, the PicoSure™ workstation is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PicoSure™ workstation is indicated for tattoo and benign pigmented lesion removal. The PicoSure™ workstation operating with the 3mm or 6mm handpiee and the FOCUS lens array is indicated for the treatment of acne scars in Fitzpatrick skin types I-IV.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PicoSure™ workstation is a high-powered, Q-switched 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Two clinical studies were conducted. One study assessed facial acne scars. In 17 patients who completed the study, a total of 46 acne scars underwent a mean of 6.3 treatments with either the 3mm or 6mm handpiece, each operated with the FOCUS lens array. Before and after photographs were evaluated by three blinded evaluators, who were able to identify correctly the before and after images in 70% of the 17 subjects. The mean improvement score (scale 0-3) was 1.9. The non-blinded treating physician reported a 100% overall satisfaction rate, scoring the improvement in 47% of subjects as "satisfied" and 53% as "extremely satisfied." Subjects reported a satisfaction rate of 87% (53% "satisfied" and 27% "extremely satisfied"). A second study was conducted on normal skin on the arm of 2 subjects and the leg of a 3rd subject to evaluate the tissue response to treatment of the FOCUS lens array. Three patients were treated with the 6mm lens with FOCUS array at 0.71J/cm2 and with the 3mm lens with FOCUS array at 2.83J/cm2. Biopsies were performed in untreated skin and in treated skin immediately post treatment, 7 days post treatment and 15 days post treatment. Treatment induced immediate focal epidermal vacuolization and small foci of degenerated keratinocytes. At days 7 and 15, skin exhibited intact epidermis with mild, superficial dermal lymphocytic infiltrates in peri-vascular pattern.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 (K)121346, Hoya ConBio RevLite (K)103118
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.
Not Found
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.
0
Image /page/0/Picture/1 description: The image is the logo for the Department of Health and Human Services (HHS). The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. Inside the circle is a symbol consisting of three stylized human profiles facing right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2016
Cynosure, Inc. Ms. Connie Hoy Vice President of Regulatory Affairs 5 Carlisle Road Westford, Massachusetts, 01886
Re: K133364 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: June 15, 2014 Received: June 17, 2014
Dear Ms. Hoy:
This letter corrects our substantially equivalent letter of July 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
This 510(K) Summary of safety and effectiveness for the PicoSure™ workstation
is submitted in accordance with the requirements of the SMDA 1990 and following guidan concerning the organization and content of a 510(K) summary.
| Applicant: | Cynosure, Inc. | |
|---|---|---|
| Address: | 5 Carlisle Road | |
| Westford, MA 01886 | ||
| USA | ||
| Contact Person: | Connie Hoy, SVP of Regulatory Affairs | |
| Telephone: | ||
| Email: | 1-781-993-2414 | |
| choy@cynosure, com | ||
| Preparation Date: | April 4, 2016 | |
| Device Trade Name: | PicoSure™ workstation | |
| Common Name: | Laser | |
| Classification Name: | Instrument, Surgical, Powered, laser | |
| 79-GEX, 21 CFR 878-48 | ||
| Legally Marketed Predicate | ||
| Device(s): | PicoSure™ workstation (K)121346 | |
| Hoya ConBio RevLite (K)103118 | ||
| Description of the PicoSure™ | ||
| Workstation: | The PicoSure™ workstation is a high-powered, Q-switched | |
| 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. | ||
| Intended use of the PicoSure™ | ||
| Workstation | The PicoSure™ workstation is indicated for tattoo and benign | |
| pigmented lesion removal. |
The PicoSure™ workstation operating with the 3mm or 6mm
handpiee and the FOCUS lens array is indicated for the
treatment of acne scars in Fitzpatrick skin types I-IV. | |
| Performance Data: | IEC 60601-1 Medical Electrical Equipment - Part 1: General
Requirements for Safety | |
| | IEC 60601-1-2 Medical Electrical Equipment 1-2 General
Requirements for basic safety and essential performance | |
| | Steam Sterilization Test Report 673257 | |
| | Software Verification and Validation Testing Report
860-7012-SRV | |
3
Results of Clinical Study:
Two clinical studies were conducted.
One study assessed facial acne scars. In 17 patients who completed the study, a total of 46 acne scars underwent a mean of 6.3 treatments with either the 3mm or 6mm handpiece, each operated with the FOCUS lens array. Before and after photographs were evaluated by three blinded evaluators, who were able to identify correctly the before and after images in 70% of the 17 subjects. The mean improvement score (scale 0-3) was 1.9. The non-blinded treating physician reported a 100% overall satisfaction rate, scoring the improvement in 47% of subjects as "satisfied" and 53% as "extremely satisfied." Subjects reported a satisfaction rate of 87% (53% "satisfied" and 27% "extremely satisfied").
A second study was conducted on normal skin on the arm of 2 subjects and the leg of a 3rd subject to evaluate the tissue response to treatment of the FOCUS lens array. Three patients were treated with the 6mm lens with FOCUS array at 0.71J/cm2 and with the 3mm lens with FOCUS array at 2.83J/cm2. Biopsies were performed in untreated skin and in treated skin immediately post treatment, 7 days post treatment and 15 days post treatment. Treatment induced immediate focal epidermal vacuolization and small foci of degenerated keratinocytes. At days 7 and 15, skin exhibited intact epidermis with mild, superficial dermal lymphocytic infiltrates in peri-vascular pattern.
| Technical
| Comparison: | Specifications | ||
|---|---|---|---|
| PicoSure™ Workstation | |||
| (current submission) | PicoSure™ Workstation | ||
| (previously cleared) | RevLite | ||
| Laser Type | Flashlamp excited Q- | ||
| switched alexandrite | Flashlamp excited Q- | ||
| switched alexandrite | Flashlamp excited Q- | ||
| switched Nd:YAG | |||
| Wavelength | 755nm | 755nm | 532 nm, 585 nm 650 nm, & |
| 1064 nm | |||
| Energy per pulse | 0.2 J/cm2 | 0.2 J/cm2 | 0.85 J/cm2 |
| Maximum Average | |||
| Fluence | 6.37 J/cm² | 6.37 J/cm² | 12 J/cm² (1064nm) |
| 5 J/cm² (532nm) | |||
| 10 J/cm² (585nm) | |||
| 6 J/cm² | |||
| (650 nm) | |||
| 1.2 J/cm² (532Lite) | |||
| Repetition 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 | 450ps-900ps | 5-20 ns |
| Spot Sizes | Zoom 2-6 mm, | ||
| Fixed 2, 3, 4, 6, 8, 10 mm | |||
| With FOCUS lens array: | |||
| 3mm 6mm | Zoom 2-6 mm, | ||
| Fixed 2, 3, 4, 6, 8, 10 mm | Fixed 2 - 8 mm (varies by | ||
| wavelength) |
4
Conclusion:
The PicoSure Workstation is substantially equivalent to other existing laser systems in commercial distribution for use in Dermatology and Plastic Surgery.
.
5
concerning the organization and content of a 510(K) summary.
| Applicant: | Cynosure, Inc. | |
|---|---|---|
| Address: | 5 Carlisle Road | |
| Westford, MA 01886 | ||
| USA | ||
| Contact Person: | Connie Hoy, SVP of Regulatory Affairs | |
| Telephone: | ||
| Email: | 1-781-993-2414 | |
| choy@cynosure, com | ||
| Preparation Date: | April 4, 2016 | |
| Device Trade Name: | PicoSure™ workstation | |
| Common Name: | Laser | |
| Classification Name: | Instrument, Surgical, Powered, laser | |
| 79-GEX, 21 CFR 878-48 | ||
| Legally Marketed | ||
| Device(s): | Predicate PicoSure™ workstation (K)121346 | |
| Hoya ConBio RevLite (K)103118 | ||
| Description of the PicoSure™ | ||
| Workstation: | The PicoSure™ workstation is a high-powered, Q-switched | |
| 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. | ||
| Intended use of the PicoSure™ | ||
| Workstation | The PicoSure™ workstation is indicated for tattoo and benign | |
| pigmented lesion removal. | ||
| The PicoSure™ workstation operating with the 3mm or 6mm | ||
| handpiee and the FOCUS lens array is indicated for the | ||
| treatment of acne scars in Fitzpatrick skin types I-IV. | ||
| Performance Data: | IEC 60601-1 Medical Electrical Equipment - Part 1: General | |
| Requirements for Safety | ||
| IEC 60601-1-2 Medical Electrical Equipment 1-2 General | ||
| Requirements for basic safety and essential performance | ||
| Steam Sterilization Test Report 673257 | ||
| Software Verification and Validation Testing Report | ||
| 860-7012-SRV |
6
Results of Clinical Study:
Two clinical studies were conducted.
One study assessed facial acne scars. In 17 patients who completed the study, a total of 46 acne scars underwent a mean of 6.3 treatments with either the 3mm or 6mm handpiece, each operated with the FOCUS lens array. Before and after photographs were evaluated by three blinded evaluators, who were able to identify correctly the before and after images in 70% of the 17 subiects. The mean improvement score (scale 0-3) was 1.9. The non-blinded treating physician reported a 100% overall satisfaction rate, scoring the improvement in 47% of subjects as "satisfied" and 53% as "extremely satisfied." Subjects reported a satisfaction rate of 87% (53% "satisfied" and 27% "extremely satisfied").
A second study was conducted on normal skin on the arm of 2 subjects and the leg of a 3rd subject to evaluate the tissue response to treatment of the FOCUS lens array. Three patients were treated with the 6mm lens with FOCUS array at 0.71J/cm2 and with the 3mm lens with FOCUS array at 2.83J/cm2. Biopsies were performed in untreated skin and in treated skin immediately post treatment, 7 days post treatment and 15 days post treatment. Treatment induced immediate focal epidermal vacuolization and small foci of degenerated keratinocytes. At days 7 and 15, skin exhibited intact epidermis with mild, superficial dermal lymphocytic infiltrates in peri-vascular pattern.
| Technical
| Comparison: | Specifications | ||||
|---|---|---|---|---|---|
| PicoSure™ Workstation | |||||
| (current submission) | PicoSure™ Workstation | ||||
| (previously cleared) | RevLite | ||||
| Laser Type | Flashlamp excited Q- | ||||
| switched alexandrite | Flashlamp excited Q- | ||||
| switched alexandrite | Flashlamp excited Q- | ||||
| switched Nd:YAG | |||||
| Wavelength | 755nm | 755nm | 532 nm, 585 nm 650 nm, & | ||
| 1064 nm | |||||
| Energy per pulse | 0.2 J/cm2 | 0.2 J/cm2 | 0.85 J/cm2 | ||
| Maximum Average | |||||
| Fluence | 6.37 J/cm² | 6.37 J/cm² | 12 J/cm² (1064nm) | ||
| 5 J/cm² (532nm) | |||||
| 10 J/cm² (585nm) | |||||
| 6 J/cm² | |||||
| (650 nm) | |||||
| 1.2 J/cm² (532Lite) | |||||
| Repetition 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 | 450ps-900ps | 5-20 ns | ||
| Spot Sizes | Zoom 2-6 mm, | ||||
| Fixed 2, 3, 4, 6, 8, 10 mm | |||||
| With FOCUS lens array: | |||||
| 3mm,6mm | Zoom 2-6 mm, | ||||
| Fixed 2, 3, 4, 6, 8, 10 mm | Fixed 2 - 8 mm (varies by | ||||
| wavelength) |
7
Conclusion:
The PicoSure Workstation is substantially equivalent to other existing laser systems in commercial distribution for use in Dermatology and Plastic Surgery.