(126 days)
No
Reasoning: The document does not mention any AI, DNN, or ML technologies. The device description and performance studies focus on laser technology and compliance with medical device standards, without any indication of AI model integration.
Yes
The device is described as being used for "treatment of benign pigmented lesions" and its intended use section mentions its application in a therapeutic capacity ("surgical and aesthetic application in the medical dermatology and general and plastic surgery"). Furthermore, one of the cited standards is IEC 60601-2-22:2019, which specifically addresses "surgical, cosmetic, therapeutic and diagnostic laser equipment".
No
The device is intended for surgical and aesthetic applications, specifically for tattoo removal and the treatment of benign pigmented lesions. It uses laser energy to perform these actions, which are therapeutic and not diagnostic.
No
The device is a physical laser system with hardware components like a host, light guide arm, treatment handle, foot switch, and power cord, clearly indicating it is not software-only. The software component mentioned is for control and validation of the hardware.
No.
The device is a laser system intended for surgical and aesthetic applications (tattoo removal, treatment of benign pigmented lesions) directly on the patient, not for in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The Medical Picosecond ND:YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Product codes
GEX
Device Description
The Medical Picosecond ND: YAG Laser System mainly consists of a host, a light guide arm, a treatment handle, a foot switch, a power cord, and other auxiliary treatment accessories. The host mainly includes laser power supply, laser, water circulation cooling system, control board, and display screen. Accessories include a foot switch, laser protective glasses, power cords, and a water filling funnel.
The Medical Picosecond ND: YAG Laser System is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).
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
Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1:2005/AMD2:2020 Medical Electrical Equipment -- Part 1: General Requirements for Basic Safety and essential performance
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC/TS 60601-4-2:2024 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
- IEC 60601-1-6:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-22:2019, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2021 Biological evaluation of medical devices -- Part 10: Tests for skin sensitization
- ISO10993-23:2021 Biological evaluation of medical devices -- Part 23: Tests for irritation
No clinical study is included in this submission.
Key Metrics
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.
FDA 510(k) Clearance Letter - Medical Picosecond ND:YAG Laser System (PZ-6)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
May 14, 2025
Zhengzhou PZ Laser Slim Technology Co., Ltd.
℅ Boyle Wang
General Manager
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong
Shanghai, 200120
China
Re: K250041
Trade/Device Name: Medical Picosecond ND: YAG Laser System (PZ-6)
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: April 15, 2025
Received: April 15, 2025
Dear Boyle Wang:
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.
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K250041 - Boyle Wang Page 2
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" (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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250041 - Boyle Wang Page 3
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. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.05.14 21:16:01 -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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250041
Device Name: Medical Picosecond ND: YAG Laser System (PZ-6)
Indications for Use (Describe)
The Medical Picosecond ND:YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
Name: Zhengzhou PZ Laser Slim Technology Co., Ltd.
Address: Room 201, 2nd Floor, Building 2, No. 52 Hongsong Road, High-tech Development Zone, 450001 Zhengzhou City, Henan Province, P.R.China
Tel: 86-18403935976
Contact: Junmei Li
Designated Submission Correspondent
Contact: Mr. Boyle Wang
Name: Shanghai Truthful Information Technology Co., Ltd.
Address: Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China
Tel: +86-21-50313932
Email: Info@truthful.com.cn
Date of Preparation: Jan.03rd, 2025
2.0 Device Information
Trade name: Medical Picosecond ND: YAG Laser System
Common name: Powered Laser Surgical Instrument
Classification name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Model: PZ-6
Production code: GEX
Regulation number: 21CFR 878.4810
Classification: Class II
Panel: General & Plastic Surgery
3.0 Predicate Devices and Reference Device
Predicate Device:
Page 6
510(k) Summary
Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.
Trade/Device Name: PicoSecond Nd: YAG Laser System
510(k) number: K200116
Reference Device 1:
Manufacturer: AMI Inc.
Trade/Device Name: PICO LEGEND Nd:YAG Laser System
510(k) number: K233007
Reference Device 2:
Manufacturer: Beijing ADSS Development Co., Ltd.
Trade/Device Name: Picosecond Laser System
510(k) number: K220268
4.0 Device Description
The Medical Picosecond ND: YAG Laser System mainly consists of a host, a light guide arm, a treatment handle, a foot switch, a power cord, and other auxiliary treatment accessories. The host mainly includes laser power supply, laser, water circulation cooling system, control board, and display screen. Accessories include a foot switch, laser protective glasses, power cords, and a water filling funnel.
The Medical Picosecond ND: YAG Laser System is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).
5.0 Indication for Use Statement
The Medical Picosecond ND: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
6.0 Comparison to the Predicate Device
Page 7
510(k) Summary
| Item | Subject device K250041 | Predicate device K200116 | Reference device 1 K233007 | Reference device 2 K220268 |
|---|---|---|---|---|
| Trade/Device Name | Medical Picosecond ND: YAG Laser System | PicoSecond Nd: YAG Laser System | PICO LEGEND Nd:YAG Laser System | Picosecond Laser System |
| Manufacturer | Zhengzhou PZ Laser Slim Technology Co., Ltd. | Shanghai Apolo Medical Technology Co., Ltd. | AMI Inc. | Beijing ADSS Development Co., Ltd |
| Class & Code | Class II GEX 878.4810 | Class II GEX 878.4810 | Class II GEX 878.4810 | Class II GEX 878.4810 |
| Intended Use/Indication for Use | The Medical Picosecond ND:YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength: - Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. | The PicoSecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength: - Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. | The PICO LEGEND Nd:YAG Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. -The 1064nm wavelength of the PICO LEGEND Nd:YAG Laser 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). -The 532nm wavelength of the | The Picosecond Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength: - Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. |
Page 8
510(k) Summary
| Item | Subject device K250041 | Predicate device K200116 | Reference device 1 K233007 | Reference device 2 K220268 |
|---|---|---|---|---|
| 532nm wavelength: | - Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. | - Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. | PICO LEGEND Nd:YAG Laser System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III. | - Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. |
| Type of Use | Prescription Use | Prescription Use | Prescription Use | Prescription Use |
| Wavelength | 1064/532 nm | 1064/532 nm | 1064/532 nm (Accuracy ±10%) | 1064/532 nm |
| Pulse Duration (Pulse Width) | 300 – 500 ps | 300 – 500 ps | 300 ps - Both Modes | 500 ps – Both Modes |
| Pulse Energy | 500mJ (1064nm) 250mJ (532nm) | 500mJ (1064nm) 250mJ (532nm) | 1064nm mode: 100 - 500mJ (Adjustable by 25mJ) 532nm mode: 50 - 250mJ (Adjustable by 25mJ) | 500mJ (1064nm) 250mJ (532nm) |
| Aiming Beam | 635nm | Not Publicly Available | 635nm | 635 nm |
| Repetition Rate | 1Hz-10Hz, with a step of 1Hz | Single, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 Hz | 1Hz-10Hz, (Adjustable by 1Hz) | 1Hz-10Hz |
Page 9
510(k) Summary
| Item | Subject device K250041 | Predicate device K200116 | Reference device 1 K233007 | Reference device 2 K220268 |
|---|---|---|---|---|
| Spot size | 2mm -10mm, ±20%, with a step of 1mm, - All treatment Modes | Adjustable spot size 2~10mm | 2mm - 10mm (Adjustable by 1mm) - All treatment Modes | 2mm - 10mm - All treatment Modes |
| Maximum Average Fluence (J/cm²) | 1064 nm: 16 J/cm² 532 nm: 8 J/cm² | Not Publicly Available | 1064 nm: 15.92 J/cm² 532 nm: 7.96 J/cm² | 1064 nm: 15.5 J/cm² 532 nm: 8 J/cm² |
| Laser Type | Nd:YAG | Nd:YAG | Nd:YAG | Nd:YAG |
| Activation | foot-switch | foot-switch | foot-switch | foot-switch |
| Display | LCD Touch screen | LCD Touch screen | LCD Touch screen | LCD Touch screen |
| Cooling System | Water circulation cooling system | Cooling System | Cooling System | Internal water to air heat exchanger |
| Electrical Power | AC100-240V 50/60Hz | 120VAC 10A, 50/60Hz | Not Publicly Available | AC 230V, 50Hz |
| Beam Delivery System | Articulated Arm with Handpiece | Articulated Arm with Handpiece | Articulated arm with handpiece | Articulated arm with handpiece |
Page 10
510(k) Summary
| Item | Subject device K250041 | Predicate device K200116 | Reference device 1 K233007 | Reference device 2 K220268 |
|---|---|---|---|---|
| System dimension | 98cm × 35 cm × 180 cm | 97cm H x 48cm W x 97cm D | Not Publicly Available | 93 cm × 40 cm × 93 cm |
| System Weight (kg) | 186 kg | 130kg | Not Publicly Available | 128kg |
Page 11
510(k) Summary
7.0 Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1:2005/AMD2:2020 Medical Electrical Equipment -- Part 1: General Requirements for Basic Safety and essential performance
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC/TS 60601-4-2:2024 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
- IEC 60601-1-6:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-22:2019, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2021 Biological evaluation of medical devices -- Part 10: Tests for skin sensitization
- ISO10993-23:2021 Biological evaluation of medical devices -- Part 23: Tests for irritation
Software Information:
Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
8.0 Clinical Test Conclusion
No clinical study is included in this submission.
9.0 Conclusion
Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. And based on the performance
Page 12
510(k) Summary
testing and compliance with acceptable voluntary standards, we believe the subject device is substantially equivalent to its predicate device.