(61 days)
No
The summary describes a laser system for tattoo and lesion removal and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the treatment of various medical conditions such as acne scars, wrinkles, and benign pigmented lesions.
No
The device description and intended use indicate that the PicoSure Workstation is used for treatment (tattoo removal, pigmented lesion removal, acne scars, wrinkles) by delivering laser energy, not for diagnosis.
No
The device description clearly states it is a "high-powered, Alexandrite system that delivers laser energy" and includes physical components like handpieces and an articulated arm, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for treatment of various skin conditions (tattoo removal, benign pigmented lesions, acne scars, wrinkles). IVDs are used for diagnosis of diseases or conditions.
- Device Description: The description details a laser system that delivers energy to the skin. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on clinical effectiveness and safety of the treatment, not on diagnostic accuracy.
Therefore, the PicoSure Workstation is a therapeutic laser device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
755mm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma. 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.
532nm:
The PicoSure 532-nm delivery system is indicated for tattoo removal and benign pigmented lesions removal in Skin Types I-III.
1064nm:
The PicoSure 1064-nm 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 treatment through a variety of
spot sizes, fluences and repetition rates. Laser activation is by
footswitch. In addition to the 755nm handpiece, optional 532nm
Laser Delivery System and/or 1064nm Laser Delivery System
can replace the 755nm handpiece at the distal end of the
articulated arm. These Delivery Systems convert the 755nm
laser energy into a 532nm wavelength or a 1064 nm wavelength
and are available in multiple spot sizes.
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)
A literature search was conducted to identify peer reviewed, published articles in which the Picosure device was used to treat specific benign pigmented lesions nevus of Ota, Hori macules (nevus of Hori), and melasma. Six articles were identified that reported prospective studies that were controlled or randomized and that treated at least ten individuals with the target pigmented lesion using the PicoSure at 755nm. These studies reported acceptable clinical effectiveness and safety.
There were no serious adverse events reported in the publications. Side effects reported in the studies were primarily transient and included common acceptable side effects for laser treatments as described in the product labeling.
The clinical data submitted demonstrates that the PicoSure device utilizing the 755nm wavelength is safe and effective for the treatment of specific benign pigmented lesions nevus of Ota, Hori macules (nevus of Hori), and melasma.
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 (K173199)
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.
RevLite Q-Switched Nd:YAG Laser System (K133254)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 30, 2021
Cynosure LLC Michael King Regulatory Affairs Specialist III 5 Carlisle Road Westford, Massachusetts 01886
Re: K210226
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: January 26, 2021 Received: January 28, 2021
Dear Michael King:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) KPending
Device Name PicoSure™ Workstation
Indications for Use (Describe)
755mm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma. 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.
532nm:
The PicoSure 532-nm delivery system is indicated for tattoo removal and benign pigmented lesions removal in Skin Types I-III.
1064nm:
The PicoSure 1064-nm 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
K210226 – 510(k) Summary for Cynosure PicoSure
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 | |
|---|---|
| Applicant | Cynosure, LLC |
| Address | 5 Carlisle Road, Westford MA, 01886 |
| Phone Number | 781-993-2454 |
| Fax Number | 978-256-6556 |
| Establishment Registration | |
| Number | 1222993 |
| Contact Person | Michael King |
| Preparation Date | March 22, 2021 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | PicoSure™ Workstation |
| Common or Usual Name | Laser Workstation |
| Classification Name | Powered Laser Surgical Instrument |
| Classification Panel | General & Plastic Surgery |
| Regulation | 21 CFR 878.4810 |
| Regulatory Class | II |
| Product Code(s) | GEX |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | |
| Predicate Device | PicoSure Workstation (K173199) |
| Reference Device | 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 treatment through a variety of | |
| spot sizes, fluences and repetition rates. Laser activation is by | |
| footswitch. In addition to the 755nm handpiece, optional 532nm | |
| Laser Delivery System and/or 1064nm Laser Delivery System | |
| can replace the 755nm handpiece at the distal end of the | |
| articulated arm. These Delivery Systems convert the 755nm | |
| laser energy into a 532nm wavelength or a 1064 nm wavelength | |
| and are available in multiple spot sizes. | |
| 807.92(a)(5) Intended Use of the Device | 755nm: |
| The PicoSure Workstation is indicated for tattoo and benign | |
| pigmented lesions removal including but not limited to: Nevus | |
| of Ota, Hori macules (nevus of Hori), and Melasma. 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. | |
| 532nm: | |
| The PicoSure 532-nm delivery system is indicated for tattoo | |
| removal and benign pigmented lesions removal in Skin Types I- | |
| III. | |
| 1064nm: | |
| The PicoSure 1064-nm delivery system is indicated for tattoo | |
| and benign pigmented lesions removal. | |
| 807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to | |
| the Predicate | There have been no changes to the technological characteristics |
| of the device compared to the predicate PicoSure Workstation | |
| (K173199). A review of clinical literature was conducted to | |
| support the addition of specific indications nevus of Ota, Hori | |
| macules (nevus of Hori), and melasma to the general | |
| indications for use of the PicoSure Workstation. | |
| Please refer to the Laser System Specification comparison table | |
| below. | |
| RevLite (K133254) is being included as a reference device for | |
| this submission. PicoSure was originally cleared under | |
| K121346, using RevLite as a predicate device. |
4
807.92(b)(1) Non-clinical tests submitted- N/A - No non-clinical tests submitted
807.92(b)(2) Clinical tests submitted - A literature search was conducted to identify peer reviewed, published articles in which the Picosure device was used to treat specific benign pigmented lesions nevus of Ota, Hori macules (nevus of Hori), and melasma. Six articles were identified that reported prospective studies that were controlled or randomized and that treated at least ten individuals with the target pigmented lesion using the PicoSure at 755nm. These studies reported acceptable clinical effectiveness and safety.
There were no serious adverse events reported in the publications. Side effects reported in the studies were primarily transient and included common acceptable side effects for laser treatments as described in the product labeling.
5
807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted – The clinical data submitted demonstrates that the PicoSure device utilizing the 755nm wavelength is safe and effective for the treatment of specific benign pigmented lesions nevus of Ota, Hori macules (nevus of Hori), and melasma. We therefore conclude that the subject device is substantially equivalent to the PicoSure Workstation predicate device cleared in K173199.
6
Indications for Use
| PicoSure Workstation | PicoSure Workstation | RevLite Q-Switched Nd: YAG Laser System |
|---|---|---|
| (K210226) | (K173199) | (K133254) |
| 755mm: | ||
| The PicoSure Workstation is indicated | ||
| for tattoo and benign pigmented lesions | ||
| removal including but not limited to: | ||
| Nevus of Ota, Hori macules (nevus of | ||
| Hori), and Melasma. 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. | ||
| 532mm: | ||
| The PicoSure 532-nm delivery system is | ||
| indicated for tattoo removal and benign | ||
| pigmented lesions removal in Skin | ||
| Types I- III. | ||
| 1064nm: | ||
| The PicoSure 1064-nm delivery system | ||
| is indicated for tattoo and benign | ||
| pigmented lesions removal. | 755 nm: | |
| The PicoSure Workstation is indicated | ||
| for tattoo and benign pigmented lesions | ||
| removal. The PicoSure Workstation | ||
| with the 2mm 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 | ||
| and benign pigmented lesion removal in | ||
| Skin Types I-III. | ||
| 1064 nm: | ||
| The PicoSure 1064 nm Laser Delivery | ||
| System is indicated for tattoo and benign | ||
| pigmented lesions removal. | 1064 nm: | |
| Tattoo Removal (dark ink: blue and black) Dermal | ||
| Pigmented Lesions; including but not limited to; Nevus of | ||
| Ota, Lentigines, Nevi, Melasma and Café-au-lait | ||
| Removal or lightening of hair with or without adjuvant | ||
| preparation. | ||
| Skin Resurfacing for Acne Scars and Wrinkles | ||
| Benign cutaneous lesions; including but not limited to: | ||
| striae and scars (excludes the 650nm wavelength) | ||
| Reduction of red pigmentation in hypertrophic and keloid | ||
| scars where vascularity is an integral part of the scar | ||
| (excludes the 650nm wavelength) | ||
| 532nm: | ||
| (nominal delivered energy of 585nm and 650nm with the | ||
| Optional Multilite Dye Laser Handpiece) | ||
| Tattoo removal (light ink: red, sky blue, green) Vascular | ||
| lesions including but not limited to: port wine birthmarks, | ||
| telangiectasias, spider angioma, cherry angioma, spider | ||
| nevi | ||
| Epidermal Pigmented lesions; including, but not limited to: | ||
| café-au-lait birthmarks, solar lentigines, senile lentigines, | ||
| Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis | ||
| Skin Resurfacing for Acne Scars and Wrinkles | ||
| Benign cutaneous lesions; including but not limited: striae | ||
| and scars (excludes the 650nm wavelength) | ||
| Reduction of red pigmentation in hypertrophic and keloid | ||
| scars where vascularity is an integral part of the scar | ||
| (excludes the 650nm wavelength) |
7
Laser System Specifications
| Description | PicoSure Workstation
(K210226) | | | PicoSure Workstation
(K173199) | | | RevLite Q-Switched Nd: YAG
Laser System (K133254) | |
|---------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------|----------------------------------------|------------------------------------------------------|-------|
| Laser Type | Nd:YVO4 | Frequency
Doubled
Nd:YVO4 | Alexandrite | Nd:YVO4 | Frequency
Doubled
Nd:YVO4 | Alexandrite | Nd:YAG | |
| Wavelength (nm) | 1064 nm | 532 nm | 755 nm | 1064 nm | 532 nm | 755 nm | 1064nm | 532nm |
| Maximum
Average Fluence
(J/cm²) | 3.6 J/cm² | 1.5 J/cm² | 6.37 J/cm² | 3.6 J/cm² | 1.5 J/cm² | 6.37 J/cm² | 8 J/cm² | |
| Repetition Rate
(Hz) | 1, 2.5, 5,10 | 1, 2.5, 5, 10 | Single Shot,
1, 2.5, 5, 10 | 1, 2.5, 5,10 | 1, 2.5, 5, 10 | Single Shot,
1, 2.5, 5, 10 | Single shot, 1, 2, 5, 10 Hz | |
| Pulse Width | 450- 900 ps | 450- 900 ps | | 450- 900 ps | 450- 900 ps | | 7 – 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 1.4 –
4.0 mm | Fixed 1.5 –
3.5 mm | Zoom 2-6
mm
Fixed 6, 8,
10 mm | 2-8.5mm range with 0.1mm
increments | |
| Rx/OTC | Prescription | | | Prescription | | | Prescription | |
| Patient
Contacting
Material | 316 Stainless Steel | | | 316 Stainless Steel | | | 304 Stainless Steel
Anodized Aluminum | |
| Electrical Power | 200-240 V~, 4.5 kVA, 50/60 Hz, Single
Phase | | | 200-240 V~, 4.5 kVA, 50/60 Hz, Single
Phase | | | AC 230 V, 50/60 Hz | |
| Dimensions | 43 in (109 cm) Hx 22in (56cm) x 42in
(107cm)
Note: Height with arm extended 62in
(158cm) | | | 43 in (109 cm) H x 22in (56cm) x 42in
(107cm)
Note: Height with arm extended 62in
(158cm) | | | 31.8" (H) x 12" (W) x 28.5" (D) | |
| Weight | 375 lb (171 kg) | | | 375 lb (171 kg) | | | 131 lbs | |