Medical Picosecond ND: YAG Laser System (PZ-6)

K250041 · Zhengzhou PZ Laser Slim Technology Co., Ltd. · GEX · May 14, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K250041
• Device Name: Medical Picosecond ND: YAG Laser System (PZ-6)
• Applicant: Zhengzhou PZ Laser Slim Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 14, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Medical Picosecond ND:YAG Laser System (PZ-6) is a pulsed laser device for dermatological and surgical applications. It utilizes a host unit with a laser power supply, Nd:YAG laser source, and water-cooling system to generate 1064nm and 532nm wavelengths. The laser energy is delivered via an articulated arm and handpiece to the target tissue. Operated by a clinician in a medical setting, the device is activated via a foot switch. The system features an LCD touch screen for parameter control. By delivering picosecond-range pulses, the device targets tattoo pigments and benign pigmented lesions, facilitating their removal or treatment. The device is intended for prescription use only.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Nd:YAG laser source; 1064nm/532nm wavelengths; 300-500ps pulse duration; 500mJ/250mJ max energy; articulated arm delivery; water circulation cooling; LCD touch screen interface; AC100-240V power. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, and ISO 10993 (biocompatibility).

Indications for Use

Indicated for tattoo removal (1064nm: Fitzpatrick I-VI, black/brown/green/blue/purple; 532nm: Fitzpatrick I-III, red/yellow/orange) and treatment of benign pigmented lesions (Fitzpatrick I-IV) in dermatology and plastic surgery.

Regulatory Classification

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.

Predicate Devices

• PicoSecond Nd: YAG Laser System (K200116)

Reference Devices

• PICO LEGEND Nd:YAG Laser System (K233007)
• Picosecond Laser System (K220268)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250041 - Boyle Wang
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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
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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 [e-mail] | |
| "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." | |

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510(k) Summary

# 510(k) Summary

# K250041

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: [phone]
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: [phone]
Email: [e-mail]
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:

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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

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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. |

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510(k) Summary

| | 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. | 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. | 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. | 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 | 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 |

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510(k) Summary

| 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 |

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510(k) Summary

| 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 |

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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

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510(k) Summary

testing and compliance with acceptable voluntary standards, we believe the subject device is substantially equivalent to its predicate device.

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