Picosecond Laser treatment system (Z180)
Device Facts
| Record ID | K262628 |
|---|---|
| Device Name | Picosecond Laser treatment system (Z180) |
| Applicant | Sanhe PERFECTLASER Technology Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Oct 20, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Picosecond Laser treatment 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-IV with the following tattoo colors: red, yellow and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV
Device Story
Picosecond Laser treatment system (Z180) is a powered laser surgical instrument for dermatology and plastic surgery. Device uses Nd:YAG laser source to emit 1064nm and 532nm wavelengths in short pulses (300-500 ps). High-energy pulses target tissue to break down tattoo pigments and benign lesions via photoluminescence. Operated by clinicians in medical settings; controlled via LCD touch screen and foot-switch. Beam delivery via light guide arm with treatment head. Internal water-to-air heat exchanger manages thermal output. Output parameters (fluence, spot size, repetition rate) are adjusted by the user to match clinical requirements. Device provides non-invasive treatment; benefits include efficient pigment fragmentation for tattoo removal and lesion treatment.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via electrical safety (IEC 60601-1, IEC 60601-2-22), EMC (IEC 60601-1-2), laser safety (IEC 60825-1), and biocompatibility (ISO 10993-5, -10, -23).
Technological Characteristics
Nd:YAG laser; 1064nm/532nm wavelengths; 300-500ps pulse width; 500mJ (1064nm)/250mJ (532nm) pulse energy; 2-10mm spot size; 1-10Hz repetition rate. Internal water-to-air heat exchanger cooling. Light guide arm delivery. Complies with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2. Biocompatible materials per ISO 10993.
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).
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 Laser System (K220268)
Submission Summary (Full Text)
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**FDA U.S. FOOD & DRUG**
ADMINISTRATION
October 20, 2026
Sanhe PERFECTLASER Technology Co., Ltd.
% Ray Wang
General Manager
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5, Yihe N. Rd.
Fangshan District
Beijing, 102401
China
Re: K262628
Trade/Device Name: Picosecond Laser treatment system (Z180)
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: July 29, 2026
Received: July 29, 2026
Dear Ray 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
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K262628 - Ray Wang
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. 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 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (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 ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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.
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K262628 - Ray Wang
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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-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: 2026.10.20
22:11:31 -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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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)
K262628
Device Name
Picosecond Laser treatment system, Model: Z180
Indications for Use (Describe)
The Picosecond Laser treatment 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)
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510(k) Summary
## 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K262628
1. Date of Preparation: 2026/10/08
2. Sponsor Identification
**Sanhe PERFECTLASER Technology Co., Ltd.**
Room 1003, Building A1 (A-1), Enterprise Headquarters, Yanjiao Modern Service Industry Park Pilot Zone, South Side of Nancheng Street, East Side of Shuichang South Road, Yanjiao High-tech Zone, Sanhe City, Langfang City, Hebei Province, China
Contact Person: Yongchao Lian
Position: Quality System Engineer
Tel: +86-15201170689
Email: 876010234@qq.com
3. Designated Submission Correspondent
Mr. Ray Wang
**Beijing Believe-Med Technology Service Co., Ltd.**
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558
Fax: +86-10-56335780
Email: information@believe-med.com
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510(k) Summary
4. Identification of Proposed Device
Trade Name: Picosecond Laser treatment system
Common Name: Powered Laser Surgical Instrument
Model(s): Z180
Regulatory Information:
Classification Name: Powered Laser Surgical Instrument
Classification: II;
Product Code: GEX;
Regulation Number: 21 CFR 878.4810;
Review Panel: General & Plastic Surgery;
5. Identification of Predicate Device(s)
Predicate Device
510(k) Number: K220268
Product Name: Picosecond Laser System
Manufacturer: Beijing ADSS Development Co., Ltd.
6. Device Description:
The Picosecond Laser System adopts the seed laser amplification mode, and the pulse width ranged only within 300 ps ~ 500 ps. The maximum energy of a single pulse of 1064 nm laser is 500 mJ, and the color base of the lesion may be efficiently broken with the laser energy instantly emitted, that is, photoluminescence: The high energy accumulated by the laser is emitted instantaneously. The 1064 & 532 nm wavelength laser acts on the target tissue in a very short time (300 ps ~ 500 ps).
7. Indication For Use Statement:
The Picosecond Laser treatment 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 typesI-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
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510(k) Summary
# 8. Substantially Equivalent (SE) Comparison
Table 1 General Comparison
| Item | Proposed Device | Predicate Device K220268 | Remark |
| --- | --- | --- | --- |
| Device Name | Picosecond Laser treatment system | Picosecond Laser System | / |
| Classification Panel | General & Plastic Surgery | General & Plastic Surgery | SAME |
| Product Code | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | II | II | SAME |
| Indication for Use | The Picosecond Laser treatment 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. | 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. 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. | SAME |
| Prescription use or not | Prescription use | Prescription use | |
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510(k) Summary
Table 2 Performance Comparison
| Item | Proposed Device | Predicate Device K220268 | Remark |
| --- | --- | --- | --- |
| Laser Type | Nd:YAG | Nd:YAG | SAME |
| Wavelength | 1064 nm | 1064 nm | SAME |
| | 532 nm | 532 nm | |
| Pulse Energy | 500mJ(1064nm) | 500mJ(1064nm) | SAME |
| | 250mJ (532nm) | 250mJ (532nm) | |
| Maximum Average Fluence (J/cm²) | 1064 nm: 15.5 J/cm² | 1064 nm: 15.5 J/cm² | SAME |
| | 532 nm: 8 J/cm² | 532 nm: 8 J/cm² | |
| Spot Size | 2-10mm | 2-10mm | SAME |
| Repetition Rate | 1-10 Hz | 1-10 Hz | SAME |
| Pulse Width | 300-500ps | 500ps | SAME |
| Aiming Beam | 635nm | 635nm | SAME |
| Display | LCD Touch screen | LCD Touch screen | SAME |
| Activation | foot-switch | foot-switch | SAME |
| Cooling System | Internal water to air heat exchanger | Internal water to air heat exchanger | SAME |
| Beam Delivery System | Light guide arm with treatment head | Articulated Arm with Handpiece | SAME |
| Electrical Power | AC 110V-127V AC 200V-240V 50/60HZ | AC 230V , 50Hz | Analysis 1 |
| System dimension | 380*912*819mm | 93cm × 40 cm × 93 cm | |
| System Weight(kg) | 186 kg | 128 kg | |
# Analysis:
Analysis 1:
The proposed device is different in Dimension and Weight from the predicate device. However, the dimension and weight difference are just in physical specification and this difference will not raise any issues in safety and effectiveness. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted. Therefore, this difference will not affect safety and effectiveness of the proposed device.
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510(k) Summary
Table 3 Safety Comparison
| Item | Proposed Device | Predicate Device K220268 | Remark |
| --- | --- | --- | --- |
| EMC, Electrical and Laser Safety | | | |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | 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 |
| Patient Contact Materials and Biocompatibility | | | |
| Cytotoxicity | No Cytotoxicity | / | SAME |
| Sensitization | No evidence of sensitization | / | SAME |
| Irritation | No evidence of irritation | / | SAME |
### 8. 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:
- 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 Compatibility-Requirements And Tests
- IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification, and requirements
- 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
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10 Fourth edition 2021, 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
- Software documentation consistent with Basic Documentation level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels
### 9. Clinical Test Conclusion
No clinical study is included in this submission.
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510(k) Summary
10. Substantially Equivalent (SE) Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device (K220268).
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