(80 days)
Not Found
No
The 510(k) summary describes a laser device with standard controls (fluence, frequency, spot size) and does not mention any AI/ML capabilities, image processing, or data-driven features.
Yes.
The device is indicated for the removal of tattoos and treatment of benign pigmented lesions, which are therapeutic indications.
No
The device explicitly states its intended use is for "Removal of tattoos" and "Treatment of benign pigmented lesions," which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states that the PICOANDY is a "solid state laser" and includes physical components such as a main unit, articulated arm, handpiece, and foot switch. This indicates it is a hardware device with integrated software for control and feedback, not a software-only medical 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 a device used for treating conditions (tattoo removal and benign pigmented lesions) by applying laser energy directly to the skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a laser system that delivers energy to the skin. This aligns with a therapeutic device, not a device that analyzes samples from the body to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The PICOANDY's function is to directly interact with and modify tissue for therapeutic purposes.
N/A
Intended Use / Indications for Use
The PICOANDY is indicated for the following at the specified wavelength:
• 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
• 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PICOANDY is the solid state laser capable of delivering energy at wavelengths of 1064nm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CER 801 Subpart D)
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)
Non-Clinical Test Summary: Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with IEC 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-6 Edition 3.1 2013, IEC 60601-2-22:2019, IEC 60825-1 Edition 3.0 2014, and IEC 60601-1-2:2014 standards.
Software Validation: The PICOCAREMAJESTY contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated.
Biocompatibility: The handpiece tip material (Aluminum Powder) that contacts intact skin for a limited duration (, and PICOCAREMAJESTY ).
Performance Testing: The performance of the PICOCAREMAJESTY has been defined as follows: Laser wavelength: 1064nm±10%, 532nm±10%; Laser output power: 1064nm mode: (30 to 600)mJ, 532nm mode: (10 to 200)mJ; Pulse Width: 1064nm mode: 450-550 ps, 532nm mode: 350-400 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.
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.
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.
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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, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, conveying the organization's role in regulating food and drugs.
March 15, 2024
Won Tech Co., Ltd. Hyunsik Yoon General Manager 64 Techno 8-ro, Yuseong-gu Daejeon, 34028 Korea, South
Re: K234104
Trade/Device Name: PICOANDY (Q-Switched Nd: YAG Laser) 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 22, 2023 Received: December 26, 2023
Dear Hyunsik 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Tanisha L. Tanisha L. Hithe -S 2024.03.15 Hithe -S 09:36:02 -04'00'
Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K234104
Device Name PICOANDY (Q-Switched Nd:YAG Laser)
Indications for Use (Describe)
The PICOANDY is indicated for the following at the specified wavelength:
· 1064 mm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
· 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
· Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside it, followed by the text "WONTECH" in a sans-serif font. The "WON" part of the text is orange, while the "TECH" part is gray.
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
November 20, 2023
Submitter's Information & Contact Person [21 CFR 807.92(a)(1)] 2.
-
Name of Manufacturer: WON TECH Co., Ltd.
-
Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, 34028, Republic of Korea - Contact Name: Hyun Sik Yoon - Telephone No.: +82-10-6750-5346 +82-70-7836-0110 - Fax No.: - 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: PICOANDY
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Powered Laser Surgical Instrument | 878.4810 | GEX |
As stated in 21 CFR, parts 878.4810, this generic type of devices has been classified as Class II.
Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[ 4.
The identified predicate devices within this submission are shown as follow:
Predicate device
| 510(k) Number: | K201773 |
|---|---|
| Applicant: | Hironic Co., Ltd. |
| Classification Name: | Powered Laser Surgical Instrument |
| Trade Name: | PICOHIGH |
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Image /page/5/Picture/0 description: The image shows the Wontech logo. The logo consists of an orange circular shape with a stylized "W" inside it. To the right of the circular shape, the word "WONTECH" is written in a combination of orange and gray letters. The "WON" part of the word is in orange, while the "TECH" part is in gray.
ട്. Description of the Device [21 CFR 807.92(a)(4)]
The PICOANDY is the solid state laser capable of delivering energy at wavelengths of 1064nm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm 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.
Indications for Use [21 CFR 807.92(a)(5)] 6.
The PICOANDY is indicated for the following at the specified wavelength:
• 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
· 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
· Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no sigmificant 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 technical characteristics.
| Proposed Device | Predicate Device #1 | SE Decision | |
|---|---|---|---|
| K Number | - | K201773 | - |
| Manufacturer | WON TECH Co., Ltd. | Hironic Co., Ltd | - |
| Model | PICOANDY | PICOHI | - |
| Indications for | |||
| Use | The PICOANDY is indicated for the | ||
| following at the specified wavelength: |
• 1064 nm: Removal of tattoos for all
skin types (Fitzpatrick I-VI) to treat
the following tattoo colors: black,
brown, green, blue and purple.
• 532 nm: Removal of tattoos for
Fitzpatrick skin types I-III to treat the | The PICOHI is indicated for the
following at the specified wavelength:
• 1064 nm: Removal of tattoos for all
skin types (Fitzpatrick I-VI) to treat the
following tattoo colors: black, brown,
green, blue and purple.
• 532 nm: Removal of tattoos for
Fitzpatrick skin types I-III to treat the | Same |
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Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WON" in orange and "TECH" in gray. The logo is simple and modern, and the colors are bright and eye-catching.
| following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV. | | following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV. | | | |
|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anatomical site | Skin and subcutaneous tissue | | Skin and subcutaneous tissue | | Same |
| Wavelength | 1064 nm | 532 nm | 1064 nm | 532 nm | Same |
| Pulse Width | 350550 ps | | 275300ps | | Similar
However, pulse Width of the proposed device is higher than the predicate device, so proposed device is more safer |
| Pulse Energy | 1. Zoom 1064nm : 30 ~ 550mJ ±10%
2. Zoom 532nm : 10 ~ 200mJ ±10%
3. Collimation Mode: 38 ~ 500mJ ±10%
4. MLA (1064nm): 30 ~ 550mJ ±10%
5. MLA (532nm): 10 ~ 200mJ ±10%
6. 1064nm DOE : 30 ~ 550mJ ±10%
7. 532nm DOE : 20 ~ 200mJ ±10% | | 1. Zoom 1064nm : 10 ~ 508mJ ±20%
2. Zoom 532nm : 4 ~ 255mJ ±20%
3. Collimation Mode: 7 ~ 471mJ ±20%
4. ZMLA (1064nm): 5 ~ 508mJ ±20%
5. ZMLA (532nm): 2 ~ 255mJ ±20%
6. 1064nm DOE : 10 ~ 500mJ ±20%
7. 532nm DOE : 10 ~ 250mJ ±20% | | Similar
The range of handpiece energy output used by Predicate devices is little or no different from the range of handpiece energy output used by proposed devices (including the +20% error range claimed by the proposed manufacturer) |
| Spot Size | 2 to 10 mm(by 1mm step) | | 1.5-13 mm | | Similar
However, the range of the spot size of the proposed device is included in the range of the proposed device. |
| Pulse Repetition Rate | Max.10Hz | | Max.10Hz | | Same |
| Laser Delivery Type | Articulated Arm with Handpiece | | Articulated Arm with Handpiece | | Same |
| Handpiece | Zoom(1064nm, 532nm)
Collimated(1064nm)
MLA (1064nm, 532nm) | | Zoom(1064nm, 532nm)
Collimated(1064nm)
ZMLA (1064nm, 532nm) | | Same |
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Image /page/7/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange stylized "W" symbol 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.
| | DOE (1064nm, 532nm) | ZMLA (1064nm, 532nm)
DOE (1064nm, 532nm) | |
|-----------------------------|-----------------------------|---------------------------------------------|----------------------------------|
| Patient Contact
Material | Aluminum powder (Handpiece) | Aluminum powder (Handpiece) | Same with Predicate
Device #1 |
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Image /page/8/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 orange and gray. The "WON" part of the text is in orange, while the "TECH" part is in gray.
Non-Clinical Test Summary [21 CFR 807.92(b)(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:
· IEC 60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety
· IEC 60601-1-6 Edition 3.1 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance
-
· IEC 60601-2-22:2019 Medical electrical equipment -
Part 2-22: Particular requirements for basic safety and essential performance -
· IEC 60825-1 Edition 3.0 2014 Safety of laser products Part 1: Equipment classification, and requirements
· IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential perform
2) Software Validation
The PICOCAREMAJESTY contains MODERATE level of concern software. 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.
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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". The "WON" part of the text is in orange, while the "TECH" part is in gray.
3) Biocompatibility
| Part | Material | Patient
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|------------------------------|-----------------------------------------|--------------------|---------------------------------------|-----------------------|
| Handpiece Tip of
PICOANDY | Aluminium Powder
(Cas No. 7429-90-5) | Intact Skin | Limited
(, and PICOCAREMAJESTY ))
4) Performance Testing
The performance of the PICOCAREMAJESTY has been defined as follows.
- Laser wavelength: 1064nm±10%, 532nm±10% -
- -Laser output power: 1064nm mode: (30 to 600)mJ, 532nm mode: (10 to 200)mJ
- Pulse Width: 1064nm mode: 450-550 ps, 532nm mode : 350-400 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)]
No clinical studies were considered necessary and performed.
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 PICOANDY is substantially equivalent to predicate devices as described herein.