(184 days)
The PICOCAREMAJESTY Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)
532nm
The 532nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 10641m or 532nm at short durations. The device system consists of a main unit, an articulated ann, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated am delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
For treatment, the user can select the appropriate fluence value. The energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased by 0.1 J/cm².
The selectable fluence values are 0.2 to 16.0 J/cm². at 1064nm and 0.1 to 7.96 J/cm² at 532nm
The provided document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for a laser system called PICOCAREMAJESTY. This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study of the device against specific acceptance criteria for a new AI/medical device.
Therefore, the information required to populate a table of acceptance criteria and reported device performance for an AI-based medical device study (as implied by questions about sample size, ground truth, expert adjudication, MRMC studies, etc.) is not present in this document.
The document describes a physical laser device, not an AI software. The "software validation" section refers to the device's internal control software, not a diagnostic or AI algorithm.
However, I can extract information related to the device's specifications and performance tests that were conducted to ensure its physical operation aligns with its intended use and safety standards. This is distinct from a performance study for an AI diagnostic device.
Here's how to address the questions based on the provided document, acknowledging its limitations regarding AI-related performance studies:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the context of an AI-driven performance study (e.g., sensitivity, specificity, AUC). Instead, it provides performance specifications for the laser device itself and states that bench tests (non-clinical) were conducted to verify these.
| Characteristic | Specified Performance (Acceptance Criteria) | Reported Device Performance (Verified by Bench Tests) |
|---|---|---|
| Laser Wavelength | 1064nm ± 10%, 532nm ± 10% | Met specifications |
| Laser Output Power | 1064nm mode: (30 to 500)mJ | Met specifications |
| 532nm mode: (20 to 250)mJ | Met specifications | |
| Pulse Width | 1064nm mode: 300-400 ps | Met specifications |
| 532nm mode: 300-400 ps | Met specifications | |
| Pulse Repetition Rate | 1064nm mode: 1-10Hz | Met specifications |
| 532nm mode: 1-10Hz | Met specifications | |
| Radiation Diameter | 1064nm mode: (2 to 10mm) step: 1mm | Met specifications |
| 532nm mode: (2 to 10mm) step: 1mm | Met specifications | |
| Electrical Safety | Compliance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 | Complies (Verified) |
| Electromagnetic Compatibility | Compliance with ANSI AAMI IEC 60601-1-2:2014 & IEC 60601-1-6 Edition 3.1 2013 | Complies (Verified) |
| Biocompatibility | Compliant with ISO 10993-1 for Limited (< 24 hours) intact skin contact (Aluminum) | Complies (Verified) |
| Software Validation | Developed according to a software development process, verified and validated. | Verified and Validated |
| Laser Safety | Compliance with IEC 60825-1:2014 (Third Edition) | Complies (Verified) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "No clinical studies were considered necessary and performed." This means there was no test set of patient data as would be used for an AI diagnostic device. The "tests" were conducted on the device itself (bench tests).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical studies or human expert ground truth establishment were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical studies were performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the device's performance characteristics (e.g., wavelength, power), the "ground truth" was the physical measurement against the engineering specifications.
For safety and electromagnetic compatibility, the "ground truth" was compliance with established international standards (e.g., IEC 60601, ISO 10993).
8. The sample size for the training set
Not applicable. This is not an AI device that undergoes training on data.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device that undergoes training on data.
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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.
January 7, 2022
Won Tech Co., Ltd. Hyun Yoon General Manager 64 Techno 8-ro Yuseong-gu, Daejeon 34028 Korea, South
Re: K212127
Trade/Device Name: Picocaremajesty 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: December 3, 2021 Received: December 10, 2021
Dear Hyun Yoon:
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.
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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
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Indications for Use
510(k) Number (if known) K212127
Device Name PICOCAREMAJESTY
Indications for Use (Describe)
The PICOCAREMAJESTY Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)
532nm
The 532nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for lighter colored tattoo inks. including red and yellow inks, on patients with Fitzpatrick skin types I-III
| 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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Image /page/3/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with a stylized "W" inside, followed by the text "WONTECH". The "WON" part of the text is in orange, matching the graphic, while the "TECH" part is in gray. The overall design is clean and modern.
K212127 510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)|
January 7, 2022
2. SubmitterInformation& Contact Person [21 CFR 807.92(a)(1)]
- Name of Manufacturer: WON TECH Co., Ltd.
- Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, 34028,
- Republic of Korea
- Hyun Sik Yoon - Contact Name:
- Telephone No.: +82-10-6750-5346
- Fax No.: +82-70-7836-0110
- Email Address: yoonhs21@wtlaser.com
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.
Common name: Nd: YAG Laser System Trade name: PICOCAREMAJESTY
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Powered Laser Surgical Instrument | 878.4810 | GEX |
As stated in 21 CFR, parts 878.4810, this generic types of devices has been classified as Class II.
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Image /page/4/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with a stylized "W" inside, followed by the text "WONTECH" in a sans-serif font. The "WON" part of the text is in orange, while the "TECH" part is in gray.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate devices within this submission are shown as follow:
Predicate device
- 510(k) Number: K181272 ● WON TECH Co., Ltd. ● Applicant: Classification Name: Powered Laser Surgical Instrument ●
- Trade Name: Picocare Family
Predicate device
| • 510(k) Number: | K200166 |
|---|---|
| • Applicant: | Shanghai Apolo Medical Technology Co., Ltd |
| • Classification Name: | Powered Laser Surgical Instrument |
| • Trade Name: | PicoSecond Nd: YAG Laser System |
న్. Description of the Device [21 CFR 807.92(a)(4)]
The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 10641m or 532nm at short durations. The device system consists of a main unit, an articulated ann, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated am delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
For treatment, the user can select the appropriate fluence value. The energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased by 0.1 J/cm².
The selectable fluence values are 0.2 to 16.0 J/cm². at 1064nm and 0.1 to 7.96 J/cm² at 532nm
Indications for Use [21 CFR 807.92(a)(5)] 6.
The PICOCAREMAJESTY Laser System is intended for use in surgical and aesthetic applications in the medicalspecialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for dark
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Image /page/5/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized white "W" inside of it. To the right of the circle is the text "WONTECH" in a sans-serif font, with "WON" in orange and "TECH" in gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)
532nm
The 532nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences between the PICOCAREMAJESTY and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technicalcharacteristics.
| Proposed Device | Predicate Device #1 | Predicate Device #2 | SE Decision | |
|---|---|---|---|---|
| K Number | - | K181272 | K200116 | - |
| Manufacturer | WON TECH Co., Ltd. | WON TECH Co., Ltd. | Shanghai ApoloMedicalTechnology Co.,Ltd. | - |
| Model | PICOCAREMAJESTY | Picocare Family | PicoSecond Nd:YAG LaserSystem | - |
| Indications forUse | ThePICOCAREMAJESTY isintended for use insurgical and aestheticapplications in themedical specialties ofdermatology and generaland plastic surgery.1064nmThe 1064nm wavelengthof thePICOCAREMAJESTYsystem is indicated fortattoo removal for darkcolored tattoo inks andfor multicolored tattooscontaining dark coloredtattoo inks on patientswith all skin types(Fitzpatrick I-VI) | The Picocare Family is intended foruse in surgical and aestheticapplications in the medicalspecialties of dermatology andgeneral and plastic surgery.1064 nmThe 1064 nm wavelength of thePicocare Family system is indicatedfor tattoo removal for dark coloredtattoo inks and for multicoloredtattoos containing dark coloredtattoo inks on patients with all skintypes (Fitzpatrick I-VI).532 nmThe 532 nm wavelength of thePicocare Family system is indicatedfor tattoo removal for lightercolored tattoo inks, including redand yellow inks, on patients withFitzpatrick skin types I-III. | The PicoSecondNd: YAG LaserSystem isintended for usein surgical andaestheticapplication in themedicaldermatology andgeneral andplastic surgery asfollows:1064nmwavelength:• Removal oftattoos on all skintype (Fitzpatrickskin types I-VI)with the following | Same |
| Proposed Device | Predicate Device #1 | Predicate Device #2 | SE Decision | |
| 532nmThe 532nm wavelengthof thePICOCAREMAJESTYsystem is indicated fortattoo removal for lightercolored tattoo inks,including red and yellowinks, on patients withFitzpatrick skin types I-III | tattoo colors:black, brown,green, blue andpurple.• Treatment ofbenign pigmentedlesions onFitzpatrick skintypes I-IV.532nmwavelength:Removal oftattoos onFitzpatrick skintypes I-III withthe followingtattoo colors: red,yellow andorange.• Treatment ofbenign pigmentedlesions onFitzpatrick skintypes I-IV. | |||
| Anatomical site | Skin and subcutaneoustissue | Skin and subcutaneous tissue | Skin andsubcutaneoustissue | Same |
| Principle/Methodof Operation | The Main unit ofPICOCAREMAJESTY iselectrically to the facilitypower source. Laserenergy produced by theMain Unit is delivered tothe tissue through thearticulated arm andhandpiece. Thefootswitch is used tocommence operation ofthe laser.ThePICOCAREMAJESTY isoperated with thesoftware by controllingthe main program. Thesoftware controls all thetreatment parameters and | The Main Unit of Picocare Familyis electrically connected to thefacility power source. Laser energyproduced by the Main Unit isdelivered to the tissue through thearticulated arm and handpiece. TheFoot Switch is used to commenceoperation of the laser. The PicocareFamily is operated with thesoftware by controlling the mainprogram. The software controls allthe treatment parameters and extrafunctions to perform all treatmentprocedures. | The PicoSecondNd: YAG LaserSystem producesa pulsed beam ofcoherent nearinfrared (1064nm)and visible(532nm) light. Itcan crush lesionstissue efficient byinstantaneousemit laser energy,1064 & 532nmwavelength act onthe target tissue ina short time (300-500ps). Theoutputs of the twolasers aredesigned to be co- | Same |
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Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange stylized "W" on the left, followed by the text "WONTECH" in orange and gray. The "WON" part of the text is in orange, while the "TECH" part is in gray.
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Image /page/7/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with a stylized "W" inside, followed by the text "WONTECH" in a sans-serif font. The "WON" part of the text is in orange, while the "TECH" part is in gray.
| Proposed Device | Predicate Device #1 | Predicate Device #2 | SE Decision | ||||
|---|---|---|---|---|---|---|---|
| extra functions toperform all treatmentprocedures. | linear on the laserrail so that theirbeam paths areidentical as theyexit the lasersystem. Thisallows the use ofa single deliverysystem which canoutput either the532 nm or 1064nm wavelengths. | ||||||
| Wavelength | 1064 nm | 532 nm | 1064 nm | 532 nm | 1064 nm | 532 nm | Same |
| Pulse Width | 300~400 ps | 450 ps | 300~500 ps | Same withPredicateDevice #2 | |||
| Pulse Energy | 500mJ | 250mJ | 600mJ(1064nm) | 300mJ(532nm) | 500mJ | 250mJ | Same withPredicateDevice #2 |
| Spot Size | 2 to 10 mm | 2 to 10 mm | 2 to 10 mm | Same | |||
| Pulse RepetitionRate | Max.10Hz | Max.10Hz | Max.10Hz | Same | |||
| Laser DeliveryType | Articulated Arm withHandpiece | Articulated Arm with Handpiece | Articulated Armwith Handpiece | Same | |||
| Handpiece | Zoom handpiece (532nm,1064 nm) | Zoom handpiece (532nm, 1064 nm)and | Zoom handpiece(532nm, 1064 nm) | Same withPredicateDevice #2 | |||
| Patient ContactMaterial | Aluminum (Handpiece) | Aluminum (Handpiece) | Unknown | Same withPredicateDevice #1 |
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Image /page/8/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular icon with a stylized "W" inside, followed by the text "WONTECH" in a sans-serif font. The "WON" part of the text is in orange, while the "TECH" part is in gray.
8. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
1) Electrical Safety, Electromagnetic Compatibility Testing
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
| Standard(Edition) | Standard Title |
|---|---|
| AASI AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medicalelectrical equipment |
| ANSI AAMI IEC 60601-1-2:2014 | Medicalelectrical equipment - Part 1-2: General requirementsfor safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests |
| IEC 60601-1-6 Edition 3.12013 | Medicalelectrical equipment - Part 1-6: General requirementsfor basic safety and essential performance - Collateralstandard: Usability |
| IEC 60601-2-22 Edition 3.12012-10 | Medicalelectrical equipment - Part 2-22: Particularrequirements for basic safety andessential performance ofsurgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 60825-1:2014(ThirdEdition | Safety of laserproducts - Part 1: Equipment classification andrequirements |
2) Software Validation
The PICOCAREMAJESTY contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.
The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.
3) Biocompatibility
| Part | Material | PatientContact | Duration of Contactby ISO 10993-1 | Bio-compatibility |
|---|---|---|---|---|
| Handpiece Tip ofPICOCAREMAJESTY | Aluminium Powder(Cas No. 7429-90-5) | Intact Skin | Limited(< 24 hours) | Yes |
- The material of handpiece for the PICOCAREMAJESTY is same to previous registered material of ● own product (PICOCARE Family <510k number: K181272>)
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Image /page/9/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with a stylized "W" inside, followed by the text "WONTECH" in a sans-serif font. The "WON" part of the text is in orange, while the "TECH" part is in gray.
4) Performance Testing
The performance of the PICOCAREMAJESTY has been defined as follows.
- Laser wavelength: 1064nm ± 10%, 532nm± 10% "
- Laseroutput power: 1064nm mode: (30 to 500)mJ,532nm mode: (20 to 250)mJ -
- Pulse Width: 1064nm mode: 300-400 ps, 532nm mode : 300-400 ps -
- -Pulse repetition rate: 1064nm mode:1-10Hz, 532nm mode : 1-10Hz
- -Radiation diameter: 1064nm mode: (2 to 10mm) step: 1mm,
- 532nm mode: (2 to 10mm)step: 1mm
Clinical Test Summary [21 CFR 807.92(b)(2)] 9.
No clinical studies were considered necessary and performed.
10. Conclusion [21 CFR 807.92(b)(3)]
In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WON TECH Co., Ltd. concludes that the PICOCAREMAJESTY is substantially equivalent to predicate devices as described herein.
§ 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.