Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)
Device Facts
| Record ID | K261572 |
|---|---|
| Device Name | Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) |
| Applicant | Keyue (Hangzhou) Medical Information Technology Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Oct 13, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
755 nm: Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as a stable long-term reduction in the number of hairs regrowing when measured at 6, 9, or 12 months after the completion of a treatment course. The device is also indicated for the treatment of benign vascular lesions, benign pigmented lesions, and wrinkles. 1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins, spider veins and poikiloderma of civatte; treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis, and treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, skin tags, keratoses and plaques. The device is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the device is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as stable long-term reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Story
LPDuo is a dual-wavelength (755 nm Alexandrite and 1064 nm Nd:YAG) laser therapy instrument. Device emits laser energy to target skin structures for dermatological applications. Operated by trained clinicians in clinical settings. Laser energy interacts with chromophores in skin to achieve coagulation, hemostasis, or hair follicle destruction. Output is controlled laser pulses; clinician adjusts parameters based on lesion type or treatment goal. Benefits include non-invasive management of vascular/pigmented lesions, hair reduction, and wrinkle treatment.
Technological Characteristics
Dual-wavelength laser system (755 nm Alexandrite and 1064 nm Nd:YAG). Class II laser surgical instrument (21 CFR 878.4810).
Indications for Use
Indicated for patients requiring hair reduction, treatment of benign vascular/pigmented lesions, wrinkles, scars, striae, psoriasis, and pseudofolliculitis barbae. Applicable to both 755 nm and 1064 nm wavelengths.
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.
Submission Summary (Full Text)
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**FDA U.S. FOOD & DRUG**
ADMINISTRATION
October 13, 2026
Keyue (Hangzhou) Medical Information Technology Co., Ltd.
% Jinjing Sui
Primary Contact
King Laser Medtech Co.,Ltd
#909 Chenggong Rd., High New Technology Development Zone
Changchun, Jilin
China
Re: K261572
Trade/Device Name: Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)
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: September 10, 2026
Received: September 11, 2026
Dear Jinjing Sui:
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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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.
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
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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: 2026.10.13
19:37:30 -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: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K261572
Device Name
Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)
Indications for Use (Describe)
755 nm:
Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as a stable long-term reduction in the number of hairs regrowing when measured at 6, 9, or 12 months after the completion of a treatment course. The device is also indicated for the treatment of benign vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm:
Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins, spider veins and poikiloderma of civatte; treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis, and treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, skin tags, keratoses and plaques.
The device is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the device is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as stable long-term reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
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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