Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)

K253829 · Beijing HuaCheng Taike Technology Co., Ltd. · GEX · Feb 27, 2026 · General, Plastic Surgery

Device Facts

• Record ID: K253829
• Device Name: Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
• Applicant: Beijing HuaCheng Taike Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 27, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medical Ultra-Pico Laser Treatment System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm The 1064 nm wavelength of the Medical Ultra-Pico Laser Treatment 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). 532 nm The 532 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

Device Story

Solid-state laser system; delivers 1064nm or 532nm energy at picosecond pulse durations; consists of main unit, light guide arm, tip, spot regulator, footswitch. Operated by clinician in dermatology/plastic surgery settings. User selects frequency/energy via LCD touch panel; laser energy delivered to skin via light guide arm. System software controls treatment parameters. Intended for tattoo removal; laser energy targets tattoo ink pigments. Benefits include precise, short-pulse energy delivery for effective ink fragmentation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5, -10, -23) and electrical/laser safety (IEC 60601-1, 60601-1-2, 60601-2-22, IEC 60825-1).

Technological Characteristics

Solid-state laser; 1064nm/532nm wavelengths; 350ps pulse width; 1-10Hz repetition rate; 2-10mm spot size. Aluminum light guide arm tip. Electrical power source. Software-controlled parameters. Biocompatibility per ISO 10993. Safety compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.

Indications for Use

Indicated for tattoo removal. 1064 nm: dark and multicolored tattoos on all skin types (Fitzpatrick I-VI). 532 nm: lighter colored tattoos (red/yellow) on Fitzpatrick skin types I-III.

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

• PICOCAREMAJESTY (K212127)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

February 27, 2026

Beijing HuaCheng Taike Technology Co., Ltd.
% Lena Zhang
RA Manager
Tianjin Xinnuocheng Medical Technology Co., LTD.
Rm. 1505, Wanhai Bldg., Dazhigu Sub-District
Hedong District
Tianjin, 300170
China

Re: K253829
Trade/Device Name: Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
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: November 28, 2025
Received: December 1, 2025

Dear Lena Zhang:

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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K253829 - Lena Zhang
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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 Management System Regulation (QMSR) (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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K253829 - Lena Zhang
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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,

YAN FU -S
Digitally signed by YAN FU -S
Date: 2026.02.27 18:27:48
-05'00"

for 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 (6/20)
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: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253829 | |
| Device Name Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | |
| Indications for Use (Describe) The Medical Ultra-Pico Laser Treatment System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm The 1064 nm wavelength of the Medical Ultra-Pico Laser Treatment 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). 532 nm The 532 nm wavelength of the Medical Ultra-Pico Laser Treatment 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) ☑ 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 # K253829

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation: 2025/11/28

2. Sponsor Identification

Beijing HuaCheng Taike Technology Co., Ltd.

Room 402, 4th Floor, Building 4, Courtyard 5, South Third Street, Huoxian Town, Tongzhou District, 101113 Beijing,P.R.China.

Contact Person: Wang Peng

Position: Management Representative

Tel: [phone]

Email: [e-mail]

3. Designated Submission Correspondent

Ms. Lena Zhang

Tianjin Xinnuocheng Medical Technology Co., LTD.

Room 1505, Wanhai Building, Dazhigu Sub-district, Hedong District Tianjin, Hedong 300170 CHINA

Tel: [phone]

Email: [e-mail]

4. Identification of Proposed Device

Trade Name: Medical Ultra-Pico Laser Treatment System

Model: CM-SP-1064&532

Common Name: Powered Laser Surgical Instrument

Regulatory Information

Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Classification: II

Product Code: GEX

Regulation Number: 878.4810

Review Panel: General & Plastic Surgery
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510(k) Summary

5. Identification of Predicate Device(s)

Predicate device:
510(k) Number: K212127
Product Name: PICOCAREMAJESTY
Manufacturer: Won Tech Co., Ltd.

6. Device Description

The Medical Ultra-Pico Laser Treatment System 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, a light guide arm, a light guide arm tip, a spot regulator and a fooswitch. The laser output is delivered to the skin through the light guide arm delivery system terminated by the light guide arm tip. The energy 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 frequency and the related output energy value by pressing plus and/or minus button from the LCD display/Touch Pad located on the front of the main unit.

7. Indication For Use Statement:

The Medical Ultra-Pico Laser Treatment System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064 nm

The 1064 nm wavelength of the Medical Ultra-Pico Laser Treatment 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).

532 nm

The 532 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

8. Substantially Equivalent (SE) Comparison

Table 1 General Comparison

| Item | Proposed Device | Predicate Device K212127 | Remark |
| --- | --- | --- | --- |
| Device name | Medical Ultra-Pico Laser Treatment System | PICOCAREMAJESTY | / |

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510(k) Summary

| Classification Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| --- | --- | --- | --- |
| Classification | II | II | SAME |
| Product Code | GEX | GEX | SAME |
| Regulation Name | Laser surgical instrument for use in general and plastic surgery and in dermatology | Laser surgical instrument for use in general and plastic surgery and in dermatology | SAME |
| Indications for use | The Medical Ultra-Pico Laser Treatment System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm
The 1064 nm wavelength of the Medical Ultra-Pico Laser Treatment 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).
532 nm
The 532 nm wavelength of the Medical Ultra-Pico Laser Treatment 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 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 | SAME |
| Anatomical site | Skin and subcutaneous tissue | Skin and subcutaneous tissue | SAME |
| Principle/Method of Operation | The main unit of Medical Ultra-Pico Laser Treatment System is electrically to the facility power source. Laser energy produced by the main unit is delivered to the tissue through the light guide arm. The footswitch is used to commence operation of the laser. The Medical Ultra-Pico Laser Treatment System is operated with the software by controlling the main program. The software controls all the treatment | The Main unit of PICOCAREMAJESTY is electrically to the facility power source. Laser energy produced by the Main Unit is delivered to the tissue through the articulated arm and handpiece. The footswitch is used to commence operation of the laser.
The PICOCAREMAJESTY is operated with the software by controlling the main program. The software controls all the treatment | SAME |

3 / 5

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510(k) Summary

| | parameters and extra functions to perform all treatment procedures. | parameters and extra functions to perform all treatment procedures. | |
| --- | --- | --- | --- |
| Wavelength | 1064nm,532nm | 1064nm,532nm | SAME |
| Pulse Width | 350ps | 300 ~400 ps | Analysis(1) |
| Pulse Energy | 1064nm:500mJ
532nm:250mJ | 1064nm:500mJ
532nm: 250mJ | SAME |
| Spot Size | 2-10mm | 2 to 10 mm | SAME |
| Pulse Repetition Rate | 1-10Hz | Max.10Hz | Identical |
| Laser Delivery Type | Light guide arm with light guide arm tip | Articulated Arm with Handpiece | Analysis(2) |
| Handpiece | Zoom handpiece (532nm, 1064 nm) | Zoom handpiece (532nm, 1064 nm) | SAME |
| Patient Contact Material | Aluminum (light guide arm tip) | Aluminum (Handpiece) | SAME |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SAME |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | SAME |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SAME |

## Analysis:

Analysis(1)

The Pulse Width of the proposed device is within the predicate device, and the proposed device has passed the IEC 60601-1 test, IEC 60601-1-2 test, IEC 60601-2-22 test, IEC 60825-1 test. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

Analysis(2)

The Laser Delivery Type of the proposed device is similar with the predicate device, only the name descriptions different and the proposed device has passed the IEC 60601-1 test, IEC 60601-1-2 test, IEC 60601-2-22 test, IEC 60825-1 test. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

## 9. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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510(k) Summary

- ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Fourth edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
- ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation
- IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.1 2020-09, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-22 Edition 4.0 2019-11, 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

10. Clinical Test Conclusion

No clinical study is included in this submission.

11. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device PICOCAREMAJESTY (K212127).